Shandong Xinhua Pharmaceutical Co., Ltd
Hutian Chemical Industrial Zone, Zibo, Shandong, 255075, China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Professional Disposables International Inc.
Two Nice-Pak Park, Orangeburg, NY, 10962-1376, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Teligent Pharma US, LLC
105 Lincoln Avenue, Buena, NJ, 08310, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
|
Regulatory Partner(s) |
General GMP observations |
Tender Corporation
944 Industrial Park Rd, Littleton, New Hampshire, 03561-3956, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Akorn Inc.
1222 West Grand Ave
Decatur, IL
USA, 62522-1412 |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Akorn Inc.
72 Veronica Ave, Somerset NJ, 08873, USA |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Pharmasol Corporation
1 Norfolk Avenue,
South Easton, Massachusetts,
02375, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Acharya Chemicals
W41 &W42, MIDC Industrial estate - Morivali Village, 421501 AMBARNATH (W) (Dist Thane), 42150, India |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Actavis Laboratories, FL. Inc.,
4955 Orange Drive, Davie, Fort Lauderdale, Florida, USA, 33314 |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified.
- Issued terms and conditions to Canadian importer(s)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Agila Onco Therapies Ltd.
Plot No. 284/B Bommasandra Jigani Link Road, Industrial Area, Bangalore, Kamataka, India |
- Non-compliant rating issued
- No further action required by Health Canada at this time
Related recalls and alerts:
|
- Regulatory Partner(s)
- Canadian importer(s)
|
General GMP observations |
AGILA SPECIALTIES PRIVATE LTD.
Opp II M, Bilekahalli, Bannerghatta Road, Bangalore, Karnataka,
India - 560 076 |
- Canadian importer(s) contacted by Health Canada for information
- No critical risks identified to date
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
AGILA SPECIALTIES PRIVATE LTD., SPECIALTY FORMULATION FACILITY (SFF)
19A, Plot No. 284-B/1 Bommasandra Jigani Link Road, Anekal Taluk, Bangalore India - 560 105 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Requested voluntary quarantine of non-medically necessary products
- Voluntary quarantine in place
- Issued terms and conditions to Canadian importer(s)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
AllerQuest LLC
10 Farmington Valley Drive, Suite 106
Plainville, Connecticut
06062-1182, United States |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Terms and Conditions applied
|
Regulatory Partner(s) |
General GMP observations |
Amanta Healthcare Ltd.
Plot No 876 NH No 8, Hariyala Matar Kheda, Gujarat, 387411, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Issued terms and conditions to Canadian importer(s)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Antibioticos do Brasil
Rod. Professor Zeferino Vaz, Km135-SP332, Cosmopolis, Sao Paulo, Brazil 13150-000 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Issued terms and conditions to Canadian importer(s)
|
Regulatory Partner(s) |
General GMP observations |
Anuh Pharma Ltd
E-17/3 & E 17/4 M.I.D.C. Tarapur, Taluka Palghar, District Thane, India-401 506 Boisar, Maharashtra |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Apotex Pharmachem India Private Limited (APIPL)
Plot No. 1A, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bangalore, Karnataka, India |
Related recalls and alerts:
March 14, 2016: Health Canada issued a new decision which imposed no terms and conditions on Apotex's Establishment Licences for products fabricated at APIPL and ARPL. As such, products fabricated at these two sites are not subject to any import restrictions. This decision was based on all available information, including new information provided by Apotex. |
Health Canada
Regulatory Partner(s) |
Data integrity
General GMP observations |
Apotex Research Private Limited (ARPL)
Plot No. 1 and No. 2, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bangalore, India |
Related recalls and alerts:
March 14, 2016: Health Canada issued a new decision which imposed no terms and conditions on Apotex's Establishment Licences for products fabricated at APIPL and ARPL. As such, products fabricated at these two sites are not subject to any import restrictions. This decision was based on all available information, including new information provided by Apotex. |
Health Canada
Regulatory Partner(s) |
Data integrity
General GMP observations |
Apotex Research Private Limited (ARPL)
Plot No. 1 and No. 2, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bangalore, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Aurobindo Pharma Limited
Unit-1, Sy. No. 379, 385, 386, 388-396, Borpatla Village, Hatnoora Mandal, Sangareddy District, Telangana, 502296, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Aurobindo Pharma Ltd,
Unit 11, Pydibhimavaram, Ranasthalam (Mandal), Srikakulam District, AP, 532409, India |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified.
- Issued terms and conditions to Canadian importer(s)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
B. Braun Medical Inc.
2525 McGaw Avenue
Irvine, CA, 92614-5895
United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Baxter HealthCare Corp
Jayuya Plant, 250 State, Road 144, Jayuya, PR, 664, United States |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Bayer S.A
Km 14.5 Calzada Roosevelt, Zona 3 De Mixco,
Guatemala, N/A, 1901, Guatemala |
- Canadian importer(s) contacted by Health Canada for information
- Medically necessary products identified
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Issued terms and conditions to Canadian importer(s)
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
| Beauty Manufacturing Solutions Corp. 1250 Freeport Parkway, Coppell, Texas |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Beijing Taiyang Pharmaceutical Industry Co Ltd
No. 1 Shuangqiao (E) Road, Chaoyang, Beijing China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity |
Bend Research Inc
20503 Builders Street, Bend, Oregon, USA, 97701 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Issued terms and conditions to Canadian importer(s)
- Removed Terms and Conditions from Canadian importer(s)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity
General GMP observations |
Biocon Limited, Works Unit II
Plot Nos 2-4, Phase IV, Bommasandra-Jigani Link Road
Bangalore, Karnataka
India 560099 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Cadila Pharmaceuticals Limited.
294, G.I.D.C. Industrial Estate, Ankleshwar, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No critical risks identified to date
- Health Canada on-site inspection [July 18, 2016]
- Health Canada on-site re-inspection [January 23, 2017]
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Celltrion, Inc.
23 Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
ChemRite CoPac Inc.
19725 W. Edgewood Dr., Lannon, WI, USA |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
| Cheng Fong Chemical Co. Ltd. No. 19, Gong 4th Road, Dayuan district, Taoyuan City 337, Taiwan |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Issued terms and conditions to Canadian importer(s)
|
Regulatory Partner(s) |
General GMP observations |
Chongqing Pharma Research Institute Co., Ltd.
No. 565 Tushan Road, Nanan
District, Chongqing, China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity |
Cipla Limited
Unit III L-139, S-103 & M-62 Verna Industrial Estate, Verna, Salcette, Goa, 403 722, India |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Cipla Limited
Unit IV L-139, S-103 & M-62 Verna Industrial Estate, Verna, Salcette, Goa, 403 722, India |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Cipla Limited
Unit VIII, S-103 To S-105, S-107 To S-112, L-147, L-147/1 & L-147/3 |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Cipla Limited
Unit X L-139, S-103 & M-62 Verna Industrial Estate, Verna, Salcette, Goa, 403 722, India |
- Canadian importer contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Claris Injectables Limited
Chacharwadi, Vasna, Sarkhej Bavla Road
Ahmedabad, Gujarat
India, 382213 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Concord Biotech Limited
1482-1486 Trasad Road, Dholka
Ahmedabad, Gujarat
387810, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Continental Manufacturing Chemist, Inc.
912 S. State St., Madrid, Iowa |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Cosmax USA
30701 Carter Street, Solon, OH, 44139, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
CTX Life Sciences Pvt. Ltd.
251-252 Sachin-Magdalla Road, G.I.D.C, Sachin, Surat, Gujarat, India, 394230 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Dishman Carbogen Amcis Limited
Located at Survey No. 47 & 48, Paiki Sub Plot No. 1, Taluka Sanand, District Ahmedabad, Village Lodariyal, Gujarat, 382 220, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Divi's Laboratories Ltd.
Unit 2, Chippada Village, Bheemunipatnam, Visakhapatnam, Andhra Pradesh, 531 162, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Issued terms and conditions to Canadian importer(s)
- Health Canada on-site inspection [November 13, 2017]
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity
General GMP observations |
Dr. Reddy's Laboratories
APIIC Ind. Est, Unit VI Pydibhimavarma (Village) Ranasthalam Mandal, Srikakulam District, India |
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)No medically necessary products identified at this time
- Requested voluntary quarantine
- Voluntary quarantine in place
- Issued terms and conditions to Canadian importer(s)
- Health Canada on-site inspection [September 19, 2016]
- No further action required by Health Canada at this time
Related recalls and alerts:
|
Regulatory Partner(s) |
Data Integrity
General GMP observations |
Dr. Reddy's Laboratories
Unit V Peddadevulapalli, Tripuraram Mandal, Nalgonad District, Andhra Pradesh |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity
General GMP observations |
Dr. Reddy's Laboratories
Unit VII Plot No. P1 to P9, Phase III, Duvvada, VSEZ, Visakhapatnam, Andhra Pradesh IN |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this timeNo further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity
General GMP observations |
Ei LLC
2865 N. Cannon Blvd.,
Kannapolis, North Carolina
28083-9124, US |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Emcure Pharmaceuticals Limited
Plot No. P-1 & P-2,, IT-BT Park Phase II, MIDC, Hinjwadi, Hinjwadi, Pune, Maharashtra INDIA |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- Medically necessary products identified Health Canada on-site inspection [June 14, 2016]
- No further action required by Health Canada at this time
|
Regulatory Partner(s)
Canadian importer(s) |
Data Integrity
General GMP observations |
Emergent Manufacturing Operations Baltimore, LLC
5901 East Lombard Street, Baltimore, MD, 21224, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Issued terms and conditions to Canadian importer(s)
- Health Canada on-site inspection [2021-10-25]
- No further action required by Health Canada at this time
- Related statement
|
Regulatory Partner(s) |
General GMP observations |
Emergent Manufacturing Operations Baltimore, LLC
5901 East Lombard Street, Baltimore, MD, 21224, United States
Date of information received: 2022-02-07 |
- Canadian importer(s) contacted by Health Canada for information
- Import restrictions imposed
- No further action required by Health Canada at this time
|
- Foreign Building
- Canadian Importer(s)
|
General GMP deficiencies |
EVERLIGHT CHEMICALS INDUSTRIAL CORPORATION
12, Industrial Third Rd, Kuanyin Industrial District, Kuanyin Hsiang, Taoyuan Hsien, 32853, Taiwan |
- Canadian importer(s) contacted by Health Canada for information
- No medically necessary products identified at this time
- Health Canada on-site inspection (November 9-13, 2015)
- Non-Compliant rating issued
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity |
Evertogen Life Sciences Limited
PLOT NO: S-8, S-9, S-13/P & S-14/P TSIIC, Pharma Sez
Green Industrial Park, Polepally (V),
Jadcherla (M), Mahabubnagar, Telangana, IN-509 301, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations
Data Integrity |
Glenmark Pharmaceuticals Limited
Village Kishanpura
Baddi Nalagarh Road
Baddi Solan, Himachal Pradesh, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Granules India Limited
Plot No. 160/A, 161/E, 162 & 174/A, Gagillapur Village, Qutbullapur Mandal, Ranga Reddy District, Telangana state, Hyderabad, 500043, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s |
General GMP observations |
Guangzhou Tinci Materials Technology Co. Ltd.
No.8 Kangda Road, Yunpu Industrial Zone, Huangpu Region |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
HEBEI YUXING BIO-ENGINEEERING CO. LIMITED
Xicheng District, Ningjin county, Ningjin, Heibei China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- Requested voluntary quarantine of non-medically necessary products
- Voluntary quarantine in place
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity |
Henan Lihua Pharmaceutical Co., Ltd.
Middle Of Huanghe Street, Anyang, Henan CHINA |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further actions required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Hetero Labs Ltd. Unit I
Survey No 10 I.D.A., Gaddapotharam Village,
Jinnaram Mandal, 502 319, Medak District,
Telangana, India |
- Canadian importer(s) contacted by Health Canada for information
- Health Canada has completed a GMP assessment and assessed the site as non-compliant.
- Medically necessary products identified.
- Importers cannot import active pharmaceutical ingredients or drug products that contain active pharmaceutical ingredients from this site.
- Health Canada is continuing to review information as it becomes available.
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Hetero Labs Limited
Unit V Sy.No.439-441,
458 TSIIC Formulation SEZ
Polepally Village, Jadcherla Mandal
Mahaboobnagar, Telangana
India 509301 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Hetero Labs Limited
Survey No. 10, I.D.A., Gaddapotharam Village, Jinnaram Mandal, Sangareddy District, Telangana, 502 319, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Hospira Inc.
1776 North Centennial Drive, McPherson, KS, United States, 67460-9301 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Issued Terms and Conditions to Canadian importer(s)
- Health Canada on-site inspection [July 24, 2017]
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Hospira S.P.A
Via Frosse Ardeatine 2 LIscate Italy |
- Canadian importer(s) contacted by Health Canada for information
- Medically necessary products identified
- Requested voluntary quarantine
- Voluntary quarantine not accepted due to products being medically necessary
- Issued Terms and Conditions to Canadian importer(s)
Related recalls and alerts:
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Hubei Hongyuan Pharmaceutical Technology Co. Ltd.
No. 428 Yishui North Road, Luotian County, Huanggang City, China-438 600, Fengshan Town, Hubei Province |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Hubei Hongyuan Pharmaceutical Technology Co. Ltd.
No.8 Fengshan Road, Industrial and Economic Development Zone, Luotian County, China 438 600, Huanggang City, Hubei Province |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
IDT Australia Ltd.
45 Wadhurst Drive
Boronia, Victoria
Australia |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further actions required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Imaretcioglu llac Sanayi Ltd. Sti. Samsun Serbest Bolgesi Subesi
Serbest Bolge, E Ada, 2 Parsel, Limanici, Samsun, Turkey |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
ImClone Systems LLC
50 ImClone Drive, Branchburg NJ, 08876, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Ind-Swift Laboratories Limited
Barwala Road, Bhagwanpur Village - Derabassi District Mohali, 140 507 Punjab, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No critical risks identified to date
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Indoco Remedies LimitedT
L-14, Verna Industrial
Area, Verna,
IN-403 722, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Indoco Remedies Limited
Plants II & III, L-32, 33, 34
Verna Industrial Estate
Area, Verna, Goa, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Indoco Remedies Limited - Plant II
L-32, 33, 34 Verna Industrial Area, Verna,
India, 403722 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Intas Pharmaceuticals Limited (IPL)
Plot No. 423 / P / A
Sarkhej - Bavla Highway Village Moraiya, Taluka Sanand Ahmedabad - 382213 Gujarat, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Interpharm Praha A.S.
Komoranska 955, Praha, Modrany |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- Issued Terms and Conditions to Canadian importer(s)
|
Regulatory Partner(s) |
General GMP observations |
INTERQUIM, S.A.,
C/ Joan Buscalla, 10 Sant Cugat del Valles
Barcelona, Spain |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- Issued Terms and Conditions to Canadian importer(s)
- Terms and Conditions removed
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
IPCA Laboratories Ltd
Plot 65 & 99, Dandudyog Industrial Estate, Piparia, Silvassa, Dadra & Nagar Haveli (U.T.), 396 230, India |
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Terms and Conditions for IPCA Ratlam apply to the Piparia products.
- Health Canada on-site inspection [August 19, 2016]
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
IPCA Laboratories Ltd.
1 Pharma Zone, SEZ Phase II, Sector 3, District Dhar, Pithampur, India |
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- Requested voluntary quarantine
- Voluntary quarantine in place
- Issued terms and conditions to Canadian importer(s) Health Canada on-site inspection [October 3, 2016]
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
IPCA Laboratories Ltd.
P.O. Box No. 33 Village Sejavta Ratlam, Madya Pradesh, India |
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Requested voluntary quarantine
- Voluntary quarantine in place
- Import restrictions imposed
- Issued Terms and Conditions to Canadian importer(s)
- Health Canada on-site inspection [September 26, 2016]
- No further action required by Health Canada at this time
Related recalls and alerts:
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Jiangxi Dongfeng Pharmaceutical Co., Ltd
1 Dongfeng Road, Leping Industrial Park, Leping City, Jiangxi Province, 333300, China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Jiangxi Synergy Pharmaceutical Co., Ltd.
Jiangxi Fengxin Industrial Park, China-330 700, Fengxin, Jiangxi Province |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No critical risks identified to date
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Jilin Shulan Synthetic Pharmaceutical Co. Ltd.
No. 2066 Peoples Main Road, Shulan, Jilin - China |
- Canadian importer(s) contacted by Health Canada for information
- Foreign building refused to provide GMP evidence to Importer or Health Canada for assessment
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
|
Jinan Jinda Pharmaceutical Chemistry Co. Ltd.
No. 6121 Longquan Road
Zhangqiu, Shandong Province
250 20, China |
- No medically necessary products identified at this time Non-compliant rating issued
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Jubilant Generics Limited (Roorkee)
Village Sikandarpur Bhainswal, Roorkee Dehradun Highway, Bhagwanpur, Roorkee District Haridwar, Uttarakhand, 247 661, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Jubilant Generics Limited (Roorkee)
Village Sikandarpur Bhainswal, Roorkee Dehradun Highway, Bhagwanpur, Roorkee District Haridwar, Uttarakhand, India, 247 661
Inspection start date: 2021-03-02
|
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Keshava Organics Pvt. Ltd.
T-97 & 100, MIDC-Tarapur
Dist. Thane, Maharashtra
401506 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Kolmar Korea Co. Ltd.
245 Sandan-gil
Jeonui-Myeon, Sejong-si
Republic of Korea (South) |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Kores (India) Limited
(Plot Nos. 58/1, 58/2, 59A, 65A, 65B, 65C & 66A M.I.D.C. Industrial Area Dhatav, District Raigad, Roha, Maharashtra, India - 402 116) |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Kumar Organic Products Limited
Plot No. 379, Maitri Marg, Canal Road, Luna, Taluk Padra, Vadodara, Gujarat, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Kyowa Hakko Bio Co., Ltd.
1-1 Kyowa-cho, Hofu-shi, Yamaguchi, Japan 747-8522. |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity
General GMP observations |
Laboratoires Clarins
5 rue Ampére,
Pontoise, 95300, France |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Lake Chemicals Pvt. Ltd.
21m, Attebele Industrial Area, Anekal Tauk, Bangalore, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd.
Industrial Park, Nankou;
Gucheng, Lijiang, Yunnan CHINA |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
LNK International Inc.
22 Arkay Drive, Hauppauge, NY, 11788, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
LNK International Inc.
40 Arkay Drive, Hauppauge, NY, 11788, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
LNK International Inc.
60 Arkay Drive, Hauppauge, NY, 11788, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
LNK International Inc.
100 Ricefield Lane, Hauppauge, NY, 11788, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
LNK International Inc.
145 Ricefield Lane, Hauppauge, NY, 11788, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP Observations |
Lupin Limited
Unit 2-Plot No. 2, SEZ Phase-II,
Misc., Apparel Park,
District Dhar,
Pithampur, Indore,
Madhya Pradesh,
India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Lupin Limited Unit II
Plot No. M-2 & M-2-A, Special Economic Zone Phase II, Misc. Zone, Apparel Park, Pithampur, Dist Dhar, Madhya Pradesh, 454775, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Mahendra Chemicals
B-1, 217, 218/2, G.I.D.C. Estate, Naroda
Ahmedabad, Gujarat
India |
- Canadian importer(s) contacted by Health Canada for information.
- No medically necessary products identified
- Non-Compliant rating issued
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity |
Malladi Drugs & Pharmaceuticals Ltd.
Plot 67, 68, Sipcot Industrial Complex, Vellore, Ranipet, Tamil Nadu, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Marcus Research Laboratory Inc.
1820 Delmar Blvd, St. Louis, MO, 63103, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Marksans Pharma Limited
Plot No. L-82, L-83, Verna Industrial Estate, Verna, Goa- India 403722 |
- Canadian importer(s) contacted by Health Canada for information
- No medically necessary products identified at this time
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No Canadian importers (s) importing from this facility.
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
MEGAFINE PHARMA (P) LIMITED
48 - 51/201 Plot No 31 - 35, Lakhamapur, Maharashtra INDIA |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- Requested voluntary quarantine
- Voluntary quarantine in place for 6 importers
- Voluntary quarantine not accepted by 4 importers due to alternate risk mitigation measures being implemented by importer
- Health Canada on-site inspection [April 12, 2016]
- Health Canada inspection completed
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity |
Meridian Medical Technologies
2555 Hermelin Dr., Brentwood, MO, 63144, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Micro Labs Bangalore
Plots No. 113 to 116, 4th Phase, KIADB, Bommasandra Industrial Area, Jigani Link Road, Anekal Taluk, Bangalore, India |
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- Requested voluntary quarantine
- Voluntary quarantine in place
- Issued Terms and Conditions to Canadian importer(s)
Related recalls and alerts:
|
Regulatory Partner(s) |
General GMP observations |
Micro Labs Goa
Plot No. S-155 to S-159, Phase III,
Verna Industrial Estate, Verna, Goa India |
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- Requested voluntary quarantine
- Voluntary quarantine in place
- Issued Terms and Conditions to Canadian importer(s)
- Health Canada on-site inspection [September 19, 2016]
- No further action required by Health Canada at this time
Related recalls and alerts:
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Micro Labs Tamil Nadu
92 Sipcot Industrial Complex
Hosur - Tamil Nadu, India |
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner).
- No medically necessary products identified at this time
- Requested voluntary quarantine
- Voluntary quarantine in place
- Issued Terms and Conditions to Canadian importer(s)
Related recalls and alerts:
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Minsheng Group Shaoxing Pharmaceuticals Co.
315 Tanggong Road, Paojiand Industrial Zone. Shaoxing, Zhejiang, China 312071 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- Medically necessary products identified
- Requested voluntary quarantine
- Voluntary quarantine not accepted due to products being medically necessary
- No further action required by Health Canada at this time
|
- Regulatory Partner(s)
- Canadian importer(s)
|
- Data integrity
- General GMP observations
|
Mylan Laboratories Limited
F-4 & F-12, Malegaon MIDC,
inner, Nashik-422113 India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Mylan Laboratories Limited
Unit 8, G. Chodavaram, POO Sapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535204, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Mylan Pharmaceuticals Inc.
781 Chestnut Ridge, Morgantown, West Virginia, USA |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Novacyl (Thailand)
321 Bangpoo Industrial Estate
Praeska, Muang
Sanutprakam, 10280
Thailand |
- Canadian importer(s) contacted by Health Canada for information
- No medically necessary products identified at this time
- No critical risks identified to date
- Compliant rating issued
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Novacyl Wuxi Pharmaceutical Co. Ltd.
8 Guang Shi Xi Road, Wuxi, Jiangsu, 214185, China |
- Canadian importer(s) contacted by Health Canada for information No medically necessary products identified at this time
- No critical risks identified to date
- Compliant rating issued
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Novel Laboratories, Inc.
400 Campus Drive, Somerset, NJ, 08873, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Noven Pharmaceuticals Inc.
11960 S.W. 144 Street - Miami, Florida, USA, 33186 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No critical risks identified to date
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
PAB Organics Private Limited
101-103, GIDC, Nandesari, Vadodara, Gujarat, 391340, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Panacea Biotec Limited
Tehsil Nalagarh, Village Malpur, Baddi, District Solan, Himachal Pradesh |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
PCCA, Inc
9901 South Wilcrest, Houston, TX, 77099, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Pfizer Healthcare India Pvt. Ltd.
Plot No. 111 (Part), 116, 117, 118, 119 and 123 (Part), Jawaharlal Nehru Pharma City, Special Economic Zone, Parawada Mandal, India
|
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Pharmaceutics International Inc.
103 Beaver Court, Cockeysville, MD, USA, 210303 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
| Pharmaceutics International Inc. 10819 Gilroy Rd, Hunt Valley, MD, USA, 21031 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Issued terms and conditions to Canadian importer(s)
|
Regulatory Partner(s) |
General GMP observations |
Polydrug Laboratories Pvt. Ltd.
Plot no. 37, Anand Nagar, M.I.D.C., India - 421 506 Ambernath (East), Maharashtra |
- No medically necessary products identified at this time
- Non-compliant rating issued
- No further action required by Health Canada at this time
Related recalls and alerts:
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Qilu Tianhe Pharmaceutical Company Ltd.
849 Dongjia Town, Licheng District, Jinan City, Shandong, China, 250105 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Qinhuangdao Zizhu Pharmaceutical Co., Ltd
No 10, Longhai Road, Economic & Technological Development Zon, Qinhuangdao, Hebei China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Recipharm Limited
Vale of Bardsley, Ashton-Under-Lyne, OL7 9RR, United Kingdom |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Resonance Laboratories Private Limited
No. 8C & 9A, K1ADB Industrial
Area, Bashettihalli, Doddaballapur, Bangalore, India 561203 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Sage Products Inc.
3909 Three Oaks Road, Cary, Illinois, USA |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Sancilio & Company Inc.
3874 Fiscal Ct Ste 200, Riviera Beach Florida, USA, 33404 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Sanochemia Pharmazeutika AG
Landeggerstrasse 7
Neufeld an der Leitha
2941, Austria |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Sato Kogyo Co., Ltd
9-2, Kannonji-Cho, Kashihara City, Nara Prefecture, Japan |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
SC Johnson Professional Inc. (Formerly Deb USA Inc.)
1100 Highway 27 South
Stanley, North Carolina
28164-2205, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Compliant rating issued
|
Regulatory Partner(s) |
General GMP observations |
Sekisui Medical Co., Ltd.
4-115 Matsuo, Hachimantai, Iwate Japan |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Sentiss Pharma Private Limited
Village Khera Nihla, Tehsil Nalagarh, Dist: Solan
Khera Nihla, Himachal Pradesh
174101, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Shanghai Desano Chemical Pharmaceutical Co., Ltd.
No.417 Binhai Road, Laogang Town, Pudong District, Shanghai, China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Shilpa Medicare Limited
Plot No. S-20 to S-26, Pharma SEZ, TSIIC, Green Industrial Park, Polepally Village, Jadcherla Mandal, Mahabubnagar District, Telangana, 509301, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Signa S.A. De C.V.
301 AV. Industria Automotriz, Zona Industrial Toluca, Toluca, Mexico, 50071, Mexico |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
SmithKline Beecham Limited
Clarendon Road, Worthing, West Sussex, England, UK, BN14 8QH |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Spectrum Laboratory Products, Inc.
14422 South San Pedro Street
Gardena, California
90248, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Spectrum Laboratory Products, Inc.
769 Jersey Avenue
New Brunswick, New Jersey
08901-3605, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Sri Krishna Pharmaceuticals Ltd
UNIT II A-35, IDA Nacharam
Hyderabad 500 076 India |
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Requested voluntary quarantine
- Voluntary quarantine in place
- Issued Terms and Conditions to Canadian importer(s)
- Health Canada on-site inspection [July 11, 2016]
Terms and Conditions removed
- No further action required by Health Canada at this time
Related recalls and alerts:
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
| Srikem Laboratories Pvt. Ltd. Plot No. 17/24, MIDC Taloja, Navi Mumbai, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Stason Pharmaceuticals Inc.
11 Morgan, Irvine, CA, 92618, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Strides Pharma Science Limited
Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Svizera Laboratories Private Limited
Plot D-16/6 TTC Industrial Area,
MIDC
Turbhe, Navi Mumbai, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- Requested voluntary quarantine
- Voluntary quarantine in place
- No Canadian importers (s) importing from this facility
- No further action required by Health Canada at this time
|
Regulatory Partner(s)
Canadian importer(s) |
Data Integrity
General GMP observations |
Symbiotec Pharmalab Pvt. Ltd.
385/2 Pigdamber, Near Hotel Mashal, Off A.B. Road, Rau, Indore, Madhya Pradesh, 453331, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Tai Heng Industry Co., Ltd.,
2715 Long Wu Road, Building 2, Shanghai Juke Biotech Park, Shanghai, China 200231 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Takeda Pharmaceutical Company Limited
4720 Mitsui, Hikari, Yamaguchi, 743-8502, Japan |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
| Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd No 1889 Jingliu Road, Linjiang Industrial Zone, Zhejiang China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Torrent Pharmaceuticals Limited
Ahmedabad-Mehsana Highway, Taluka-Kadi, Indrad, Gujarat |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Toyobo Co Ltd
1-1 Katata 2-chom Otsu Pharmaceuticals Plant, Otsu-shi, Siga, 520-0292, Japan |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Tris Pharma Inc.
2033 Route 130, Monmouth Junction, NJ, 08852, United States |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
UNIMARK REMEDIES LIMITED
337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District
530 049, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- Requested voluntary quarantine
- No Canadian importers (s) importing from this facility
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity |
Unimark Remedies Limited (Vapi)
Plot
41/42, Phase 1 - GIDC District Valsad Pardi, Gujarat, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Issued Terms and Conditions to Canadian importer(s)
- Removed Terms and Conditions from Canadian importer(s)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
UQUIFA-Union Farmaceutica S.A.
Poligono Industrial El Pla.Avda.Puigcerda, 9 c-17 km 17.4, Llica de vall, Barcelona, 08185, Spain |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
US Pharmaceuticals, Inc.
681 Main Street, Building 27, Belleville, New Jersey |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No critical risks identified to date
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
USV Private Limited
H-17/H-18, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data integrity
General GMP observations |
Vital Laboratories Pvt Ltd (Plant I)
1416-21, 1507 1 and 2 Phase III GIDC, Vapi, 396195, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Vital Lab Private Limited Plant II
Plot No.1710 & A1-2208, Phase III GIDC Estate, Vapi, Gujarat |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
VUAB PHARMA a.s
Vltavska 53, Roztoky, CZECH REPUBLIC |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- Issued Terms and Conditions to Canadian Importer(s)No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity
General GMP observations |
Wockhardt Limited
Plot No. 138, G.I.D.C, Industrial Estate, District: Bharuch, Ankleshwar, Gujarat, 393002, India |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity
General GMP observations |
Yicheng Goto Chemical Co.Ltd.
1 Group of Gaokeng, Xiaohe, Xiaohe, Yicheng, Hebei, 441003, China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Yuki Gosei Kogyo Co. Ltd.
788 Ochiai, Joban Nishigo-Machi, Iwaki-Shi, Fukushima Japan, 972-8316 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
YUNNAN HANDE BIO-TECH. Co.Ltd
No. 3 Platform Jinding Tech-Zone, Kunming, Yunnan Province, China |
- Canadian importer(s) contacted by Health Canada for information
- Medically necessary products identified
- No critical risks identified to date
- Continuing to review evidence submitted (i.e. corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity
General GMP observations |
ZHEJIANG HISOAR PHARMACEUTICAL CO. LTD.
No. 100 Waisha Branch Rd, Jiaojiang, Taizhou City, Zhejiang Province CN |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Requested voluntary quarantine of non-medically necessary products
- Voluntary quarantine in place
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
Data Integrity |
Zhejiang Hisun Pharma Company Ltd.
46 Waisha Road, Jiaojiang District,Taizhou City, Zhejiang, China Binhai Site - Yantou Campus 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang, China |
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- Medically necessary products identified
- Requested voluntary quarantine
- Voluntary quarantine in place for 2 importers
- Voluntary quarantine not accepted by 1 importer due to alternate risk mitigation measures being implemented by importer Issued Terms and Conditions to Canadian importer(s) Health Canada on-site inspection [July 18, 2016]
- No further action required by Health Canada at this time
Related recalls and alerts:
|
Regulatory Partner(s)
Canadian importer(s) |
Data integrity
General GMP observations |
Zhejiang Hisun Pharmaceutical Co. Ltd
1 Haizheng Road, Jiaojiand District, Taizhou City, Zhejiang, 9999, China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No medically necessary products identified at this time
- Health Canada on-site inspection [May 29, 2017]
- No further action required by Health Canada at this time
|
Regulatory Partner(s)
Canadian importer(s) |
Data integrity
General GMP observations |
Zhejiang Hisun Pharmaceutical Co., Ltd.
1 Haizheng Road, Jiaojiang District, Taizhou City, Zhejiang, 318 000, China
Inspection start date: 2019-03-26 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Zhejiang Hisun Pharmaceutical Co., Ltd.
56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang, 318 000, China Inspection start date: 2019-03-26 |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Zhejiang Huahai Pharmaceutical Co., Ltd
104 National Road, Xunqiao, Huahai Xunqiao Site, Linhai, Zhejiang, 317 024, China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Zhejiang Huahai Pharmaceutical Co., Ltd. - Chuannan Site
Coastal Industrial Zone, Duqiao, Linhai, Zhejiang, 317016, China |
- Canadian importer(s) contacted by Health Canada for information
- Health Canada has completed a GMP assessment and assessed the site as non-compliant
- Importers cannot import drugs that contain active pharmaceutical ingredients from this site
- Health Canada is continuing to review information as it becomes available.
- Issued terms and conditions to Canadian importer(s)
- No further action required by Health Canada at this time
|
Regulatory Partner(s) |
General GMP observations |
Zhejiang Medicine Co. Ltd
Xinchang Pharmaceutical Factory, 98 East Xinchang Dadao Road, Xinchang, Zhejiang, 312500 China |
- Canadian importer(s) contacted by Health Canada for information
- Continuing to review evidence submitted (i.e corrective actions, information from regulatory partner)
- No further action required by Health Canada at this time
|
Regulatory Partner(s)
Canadian importer(s) |
Data integrity
General GMP |
