Inspection tracker: Drug manufacturing establishments
As part of Health Canada's ongoing commitment to openness and transparency, the Department is publishing information regarding emerging issues identified through our drug inspection program.
This tracker provides a snapshot of the potential health and safety issues Health Canada is tracking with companies that fabricate, package/label, test, wholesale, distribute or import drugs for sale in Canada. The information in the chart will expand to eventually include details about affected Canadian companies and products.
How the inspection tracker works
- Health Canada responds to potential risks as soon as we hear about them whether from our own inspections, the companies themselves, adverse reaction reports or from our regulatory partners.
- The tracker highlights actions Health Canada is taking such as: requests for voluntary quarantine, stop sales, import restrictions, or product recalls. It also indicates those circumstances where no action has been warranted.
- Even if a company is listed on the tracker, it doesn't necessarily mean there is an immediate risk to the health of Canadians. It means Health Canada is looking into a potential issue.
- Health Canada will continue to take action to manage risks identified to the health of Canadians using the most appropriate level of intervention, proportional to the risk to health.
- This tracker currently doesn't list specific drugs and health products affected but links to Recalls and Safety Alerts if a risk has been linked to specific products on the Canadian market.
- This tracker is updated regularly.
- Once an item is listed in the closed section, it indicates that there is no further action being taken by Health Canada at this time and there will be no more updates regarding this item.
- Last update: January 24, 2023
Establishment | Status of issue | Source of information under review | Primary reason for action |
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Abraxis Bioscience LLC 620 N. 51st Avenue, Phoenix, AZ, 85043, United States |
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Regulatory Partner(s) | General GMP observations |
Advanced Cosmetic Research Laboratories Inc 20550 Prairie St, Chatsworth, CA, 91311, United States |
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Regulatory Partner(s) | General GMP observations |
Cangene BioPharma LLC dba Emergent BioSolutions 1111 South Paca Street, Camden Industrial Park, Baltimore, MD, 21230, United States |
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Regulatory Partner(s) | General GMP observations |
Centrient Pharmaceuticals India Private Limited Bhai Mohan Singh Nagar, Toansa, Distt.SBS, Nagar (Nawanshahr), Punjab, 144 533, India |
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Regulatory Partner(s) | General GMP observations |
CTX Lifesciences Private Ltd. Block No. 251-252 Sachin-Magdalla Road, GIDC, Sachin, Surat 394230 Gujarat, India |
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Regulatory Partner(s) | General GMP observations |
Glenmark Pharmaceuticals Limited Plot No. S-7, Colvale Industrial Estate, Colvale, Bardez, Goa, 403513, India |
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Regulatory Partner(s) | General GMP observations |
Glenmark Pharmaceuticals Limited, Unit I Village Kishanpura, Baddi Nalagarh Road, Baddi, Solan, Himachal Pradesh India |
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Regulatory Partner(s) | General GMP observations |
Jurox Pty Ltd. 85 Gardiner Street, Rutherford, New South Wales, 2320, Australia |
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Regulatory Partner(s) | General GMP observations |
Lupin Limited T-142, M.I.D.C. Tarapur, Via Boisar, Tal Palghar, Maharashtra, 401 506, India |
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Regulatory Partner(s) | General GMP observations |
Lupin Limited Unit 1 Unit 1, 198-202 New Ind Area No 2, Mandideep Madhya Pradesh, India |
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Regulatory Partner(s) | General GMP observations |
Nephron Pharmaceuticals Corporation 4500 12th Street Extension, West Columbia, SC, 29172, United States |
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Regulatory Partner(s) | General GMP observations |
Sun Pharmaceutical Industries Limited Halol Baroda Highway, Halol, Gujarat, 389 350, India |
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Regulatory Partner(s) | General GMP observations |
Trifarma S.P.A Via Pavese 2, Rozzano, N/A, 20089, Italy |
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Regulatory Partner(s) | General GMP observations |
Establishment | Status of issue | Source of information under review | Primary reason for action |
---|---|---|---|
Accu Bio-Chem Laboratories 1755 Victory Boulevard, Glendale, CA, 91201, United States |
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Regulatory Partner(s) | General GMP observations |
Akorn Inc. 1222 West Grand Ave Decatur, IL USA, 62522-1412 |
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Regulatory Partner(s) | General GMP observations |
Akorn Inc. 72 Veronica Ave, Somerset NJ, 08873, USA |
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Regulatory Partner(s) | General GMP observations |
Acharya Chemicals W41 &W42, MIDC Industrial estate - Morivali Village, 421501 AMBARNATH (W) (Dist Thane), 42150, India |
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Regulatory Partner(s) | General GMP observations |
Actavis Laboratories, FL. Inc., 4955 Orange Drive, Davie, Fort Lauderdale, Florida, USA, 33314 |
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Regulatory Partner(s) | General GMP observations |
Advanced Accelerator Applications USA, Inc. |
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General GMP observations |
Agila Onco Therapies Ltd. Plot No. 284/B Bommasandra Jigani Link Road, Industrial Area, Bangalore, Kamataka, India |
Related recalls and alerts: |
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General GMP observations |
AGILA SPECIALTIES PRIVATE LTD. Opp II M, Bilekahalli, Bannerghatta Road, Bangalore, Karnataka, India - 560 076 |
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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 |
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Regulatory Partner(s) | General GMP observations |
AllerQuest LLC 10 Farmington Valley Drive, Suite 106 Plainville, Connecticut 06062-1182, United States |
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Regulatory Partner(s) | General GMP observations |
Amanta Healthcare Ltd. Plot No 876 NH No 8, Hariyala Matar Kheda, Gujarat, 387411, India |
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Regulatory Partner(s) | General GMP observations |
Antibioticos do Brasil Rod. Professor Zeferino Vaz, Km135-SP332, Cosmopolis, Sao Paulo, Brazil 13150-000 |
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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 |
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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 |
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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 |
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Regulatory Partner(s) | General GMP observations |
Aurobindo Pharma Ltd, Unit 11, Pydibhimavaram, Ranasthalam (Mandal), Srikakulam District, AP, 532409, India |
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Regulatory Partner(s) | General GMP observations |
B. Braun Medical Inc. 2525 McGaw Avenue Irvine, CA, 92614-5895 United States |
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Regulatory Partner(s) | General GMP observations |
Baxter HealthCare Corp Jayuya Plant, 250 State, Road 144, Jayuya, PR, 664, United States |
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Regulatory Partner(s) | General GMP observations |
Bayer S.A Km 14.5 Calzada Roosevelt, Zona 3 De Mixco, Guatemala, N/A, 1901, Guatemala |
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Regulatory Partner(s) | Data integrity General GMP observations |
Beauty Manufacturing Solutions Corp. 1250 Freeport Parkway, Coppell, Texas |
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Regulatory Partner(s) | General GMP observations |
Beijing Taiyang Pharmaceutical Industry Co Ltd No. 1 Shuangqiao (E) Road, Chaoyang, Beijing China |
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Regulatory Partner(s) | Data Integrity |
Bend Research Inc 20503 Builders Street, Bend, Oregon, USA, 97701 |
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Regulatory Partner(s) | Data Integrity General GMP observations |
Bharat Biotech International Limited Sy. No. 230, 231 and 235, Turkapally, Telangana, India, 00078 |
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Regulatory Partner(s) | General GMP observations |
Biocon Limited, Works Unit II Plot Nos 2-4, Phase IV, Bommasandra-Jigani Link Road Bangalore, Karnataka India 560099 |
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Regulatory Partner(s) | Data integrity General GMP observations |
Bioiberica S.A.U. C/Antic Cami de Tordera, 109-119, Palafolls, Barcelona, 08389, Spain |
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Regulatory Partner(s) | General GMP observations |
Cadila Pharmaceuticals Limited. 294, G.I.D.C. Industrial Estate, Ankleshwar, India |
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Regulatory Partner(s) | General GMP observations |
Celltrion, Inc. 23 Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea |
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Regulatory Partner(s) | General GMP observations |
Cetylite Industries 9051 River Road, Pennsauken, NJ, USA, 08110 |
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Regulatory Partner(s) | General GMP observations |
ChemRite CoPac Inc. 19725 W. Edgewood Dr., Lannon, WI, USA |
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Regulatory Partner(s) | General GMP observations |
Cheng Fong Chemical Co. Ltd. No. 19, Gong 4th Road, Dayuan district, Taoyuan City 337, Taiwan |
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Regulatory Partner(s) | General GMP observations |
Chongqing Pharma Research Institute Co., Ltd. No. 565 Tushan Road, Nanan District, Chongqing, China |
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Regulatory Partner(s) | Data Integrity |
Cipla Limited Unit III L-139, S-103 & M-62 Verna Industrial Estate, Verna, Salcette, Goa, 403 722, India |
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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 |
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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 |
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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 |
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Regulatory Partner(s) | General GMP observations |
Claris Injectables Limited Chacharwadi, Vasna, Sarkhej Bavla Road Ahmedabad, Gujarat India, 382213 |
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Regulatory Partner(s) | Data integrity General GMP observations |
Concord Biotech Limited 1482-1486 Trasad Road, Dholka Ahmedabad, Gujarat 387810, India |
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Regulatory Partner(s) | General GMP observations |
Continental Manufacturing Chemist, Inc. 912 S. State St., Madrid, Iowa |
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Regulatory Partner(s) | General GMP observations |
Cosmax USA 30701 Carter Street, Solon, OH, 44139, United States |
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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 |
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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 |
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Regulatory Partner(s) | General GMP observations |
Divi's Laboratories Ltd. Unit 2, Chippada Village, Bheemunipatnam, Visakhapatnam, Andhra Pradesh, 531 162, India |
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Regulatory Partner(s) | Data Integrity General GMP observations |
Dr. Reddy's Laboratories APIIC Ind. Est, Unit VI Pydibhimavarma (Village) Ranasthalam Mandal, Srikakulam District, India |
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 |
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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 |
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Regulatory Partner(s) | Data Integrity General GMP observations |
Ei LLC 2865 N. Cannon Blvd., Kannapolis, North Carolina 28083-9124, US |
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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 |
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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 |
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Regulatory Partner(s) | General GMP observations |
Emergent Manufacturing Operations Baltimore, LLC Date of information received: 2022-02-07 |
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General GMP deficiencies |
EVERLIGHT CHEMICALS INDUSTRIAL CORPORATION 12, Industrial Third Rd, Kuanyin Industrial District, Kuanyin Hsiang, Taoyuan Hsien, 32853, Taiwan |
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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 |
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Regulatory Partner(s) | General GMP observations Data Integrity |
Glenmark Pharmaceuticals Limited Village Kishanpura Baddi Nalagarh Road Baddi Solan, Himachal Pradesh, India |
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Regulatory Partner(s) | General GMP observations |
Gordon Laboratories, Inc 751 E. Artesia Blvd, Carson, CA, 90746, United States) |
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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 |
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Regulatory Partner(s | General GMP observations |
Guangzhou Tinci Materials Technology Co. Ltd. No.8 Kangda Road, Yunpu Industrial Zone, Huangpu Region |
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Regulatory Partner(s) | General GMP observations |
HEBEI YUXING BIO-ENGINEEERING CO. LIMITED Xicheng District, Ningjin county, Ningjin, Heibei China |
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Regulatory Partner(s) | Data Integrity |
Henan Lihua Pharmaceutical Co., Ltd. Middle Of Huanghe Street, Anyang, Henan CHINA |
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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 |
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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 |
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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 |
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Regulatory Partner(s) | General GMP observations |
Hospira Inc. 1776 North Centennial Drive, McPherson, KS, United States, 67460-9301 |
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Regulatory Partner(s) | General GMP observations |
Hospira S.P.A Via Frosse Ardeatine 2 LIscate Italy |
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 |
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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 |
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Regulatory Partner(s) | Data integrity General GMP observations |
IDT Australia Ltd. 45 Wadhurst Drive Boronia, Victoria Australia |
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Regulatory Partner(s) | General GMP observations |
Imaretcioglu llac Sanayi Ltd. Sti. Samsun Serbest Bolgesi Subesi Serbest Bolge, E Ada, 2 Parsel, Limanici, Samsun, Turkey |
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Regulatory Partner(s) | General GMP observations |
ImClone Systems LLC 50 ImClone Drive, Branchburg NJ, 08876, United States |
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Regulatory Partner(s) | General GMP observations |
Ind-Swift Laboratories Limited Barwala Road, Bhagwanpur Village - Derabassi District Mohali, 140 507 Punjab, India |
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Regulatory Partner(s) | Data integrity General GMP observations |
Indoco Remedies LimitedT L-14, Verna Industrial Area, Verna, IN-403 722, India |
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Regulatory Partner(s) | General GMP observations |
Indoco Remedies Limited Plants II & III, L-32, 33, 34 Verna Industrial Estate Area, Verna, Goa, India |
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Regulatory Partner(s) | General GMP observations |
Indoco Remedies Limited - Plant II L-32, 33, 34 Verna Industrial Area, Verna, India, 403722 |
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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 |
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Regulatory Partner(s) | General GMP observations |
Interpharm Praha A.S. Komoranska 955, Praha, Modrany |
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Regulatory Partner(s) | General GMP observations |
INTERQUIM, S.A., C/ Joan Buscalla, 10 Sant Cugat del Valles Barcelona, Spain |
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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 |
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Regulatory Partner(s) | Data integrity General GMP observations |
IPCA Laboratories Ltd. 1 Pharma Zone, SEZ Phase II, Sector 3, District Dhar, Pithampur, India |
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Regulatory Partner(s) | Data integrity General GMP observations |
IPCA Laboratories Ltd. P.O. Box No. 33 Village Sejavta Ratlam, Madya Pradesh, India |
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 |
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Regulatory Partner(s) | General GMP observations |
Jiangxi Synergy Pharmaceutical Co., Ltd. Jiangxi Fengxin Industrial Park, China-330 700, Fengxin, Jiangxi Province |
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Regulatory Partner(s) | General GMP observations |
Jilin Shulan Synthetic Pharmaceutical Co. Ltd. No. 2066 Peoples Main Road, Shulan, Jilin - China |
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Regulatory Partner(s) | |
Jinan Jinda Pharmaceutical Chemistry Co. Ltd. No. 6121 Longquan Road Zhangqiu, Shandong Province 250 20, China |
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Regulatory Partner(s) | Data integrity General GMP observations |
Jost Chemicals Co. 8150 Lackland Rd. Saint Louis, Missouri, US |
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Regulatory Partner(s) | General GMP observations |
Jubilant Generics Limited (Roorkee) Village Sikandarpur Bhainswal, Roorkee Dehradun Highway, Bhagwanpur, Roorkee District Haridwar, Uttarakhand, 247 661, India |
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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 |
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Regulatory Partner(s) | General GMP observations |
Keshava Organics Pvt. Ltd. T-97 & 100, MIDC-Tarapur Dist. Thane, Maharashtra 401506 |
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Regulatory Partner(s) | General GMP observations |
Kolmar Korea Co. Ltd. 245 Sandan-gil Jeonui-Myeon, Sejong-si Republic of Korea (South) |
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Regulatory Partner(s) | General GMP observations |
Kopran Research Laboratories Limited K-4/4 Additional MIDC, At&Post Birwadi, Raigad District, Mahad, Maharashtra, India, 402302 |
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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) |
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Regulatory Partner(s) | General GMP observations |
Kumar Organic Products Limited Plot No. 379, Maitri Marg, Canal Road, Luna, Taluk Padra, Vadodara, Gujarat, India |
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Regulatory Partner(s) | General GMP observations |
Kyowa Hakko Bio Co., Ltd. 1-1 Kyowa-cho, Hofu-shi, Yamaguchi, Japan 747-8522. |
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Regulatory Partner(s) | Data Integrity General GMP observations |
Laboratoires Clarins 5 rue Ampére, Pontoise, 95300, France |
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Regulatory Partner(s) | General GMP observations |
Lake Chemicals Pvt. Ltd. 21m, Attebele Industrial Area, Anekal Tauk, Bangalore, India |
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Regulatory Partner(s) | General GMP observations |
Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. Industrial Park, Nankou; Gucheng, Lijiang, Yunnan CHINA |
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Regulatory Partner(s) | General GMP observations |
LNK International Inc. 22 Arkay Drive, Hauppauge, NY, 11788, United States |
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Regulatory Partner(s) | General GMP observations |
LNK International Inc. 40 Arkay Drive, Hauppauge, NY, 11788, United States |
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Regulatory Partner(s) | General GMP observations |
LNK International Inc. 60 Arkay Drive, Hauppauge, NY, 11788, United States |
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Regulatory Partner(s) | General GMP observations |
LNK International Inc. 100 Ricefield Lane, Hauppauge, NY, 11788, United States |
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Regulatory Partner(s) | General GMP observations |
LNK International Inc. 145 Ricefield Lane, Hauppauge, NY, 11788, United States |
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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 |
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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 |
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Regulatory Partner(s) | General GMP observations |
Mahendra Chemicals B-1, 217, 218/2, G.I.D.C. Estate, Naroda Ahmedabad, Gujarat India |
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Regulatory Partner(s) | Data Integrity |
Malladi Drugs & Pharmaceuticals Ltd. Plot 67, 68, Sipcot Industrial Complex, Vellore, Ranipet, Tamil Nadu, India |
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Regulatory Partner(s) | General GMP observations |
Marcus Research Laboratory Inc. 1820 Delmar Blvd, St. Louis, MO, 63103, United States |
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Regulatory Partner(s) | General GMP observations |
Marksans Pharma Limited Plot No. L-82, L-83, Verna Industrial Estate, Verna, Goa- India 403722 |
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Regulatory Partner(s) | Data integrity General GMP observations |
Mefar Ilac Sanayii A.S. Ramazanoglu MahallesiEnsar Caddesi 20, Pendik, 34906, Turkey |
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Regulatory Partner(s) | General GMP observations |
MEGAFINE PHARMA (P) LIMITED 48 - 51/201 Plot No 31 - 35, Lakhamapur, Maharashtra INDIA |
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Regulatory Partner(s) | Data Integrity |
Megafine Pharma Ltd. 911 & 912, III Phase GIDC, Vapi, Gujarat, Maharashtra, India, 396195 |
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Regulatory Partner(s) | General GMP observations |
Meridian Medical Technologies 2555 Hermelin Dr., Brentwood, MO, 63144, United States |
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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 |
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 |
Related recalls and alerts: |
Regulatory Partner(s) | Data integrity General GMP observations |
Micro Labs Tamil Nadu 92 Sipcot Industrial Complex Hosur - Tamil Nadu, India |
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 |
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Mylan Laboratories Limited F-4 & F-12, Malegaon MIDC, inner, Nashik-422113 India |
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Regulatory Partner(s) | General GMP observations |
Mylan Laboratories Limited Unit 7, Plot No. 14, 99 & 100, IDA, Pashamylaram Phase II, Patancheru, Sangareddy District, Telangana, 502307, India. |
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Regulatory Partner(s) | General GMP observations |
Mylan Laboratories Limited Unit 8, G. Chodavaram, POO Sapatirega Mandal, Vizianagaram District, Andhra Pradesh, 535204, India |
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Regulatory Partner(s) | General GMP observations |
Mylan Pharmaceuticals Inc. 781 Chestnut Ridge, Morgantown, West Virginia, USA |
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Regulatory Partner(s) | General GMP observations |
Novacyl (Thailand) 321 Bangpoo Industrial Estate Praeska, Muang Sanutprakam, 10280 Thailand |
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Regulatory Partner(s) | General GMP observations |
Novacyl Wuxi Pharmaceutical Co. Ltd. 8 Guang Shi Xi Road, Wuxi, Jiangsu, 214185, China |
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Regulatory Partner(s) | General GMP observations |
Novel Laboratories, Inc. 400 Campus Drive, Somerset, NJ, 08873, United States |
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Regulatory Partner(s) | General GMP observations |
Noven Pharmaceuticals Inc. 11960 S.W. 144 Street - Miami, Florida, USA, 33186 |
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Regulatory Partner(s) | General GMP observations |
PAB Organics Private Limited 101-103, GIDC, Nandesari, Vadodara, Gujarat, 391340, India |
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Regulatory Partner(s) | General GMP observations |
Panacea Biotec Limited Tehsil Nalagarh, Village Malpur, Baddi, District Solan, Himachal Pradesh |
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Regulatory Partner(s) | General GMP observations |
PCCA, Inc 9901 South Wilcrest, Houston, TX, 77099, United States |
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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 |
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Regulatory Partner(s) | General GMP observations |
Pharmaceutics International Inc. 103 Beaver Court, Cockeysville, MD, USA, 210303 |
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Regulatory Partner(s) | General GMP observations |
Pharmaceutics International Inc. 10819 Gilroy Rd, Hunt Valley, MD, USA, 21031 |
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Regulatory Partner(s) | General GMP observations |
Pharmactive ilac San. ve Tic. A.S. |
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Regulatory Partner(s) | General GMP observations |
Pharmasol Corporation 1 Norfolk Avenue, South Easton, Massachusetts, 02375, United States |
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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 |
Related recalls and alerts: |
Regulatory Partner(s) | Data integrity General GMP observations |
Professional Disposables International Inc. Two Nice-Pak Park, Orangeburg, NY, 10962-1376, United States |
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Regulatory Partner(s) | General GMP observations |
Qilu Tianhe Pharmaceutical Company Ltd. 849 Dongjia Town, Licheng District, Jinan City, Shandong, China, 250105 |
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Regulatory Partner(s) | General GMP observations |
Qinhuangdao Zizhu Pharmaceutical Co., Ltd No 10, Longhai Road, Economic & Technological Development Zon, Qinhuangdao, Hebei China |
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Regulatory Partner(s) | General GMP observations |
Recipharm Limited Vale of Bardsley, Ashton-Under-Lyne, OL7 9RR, United Kingdom |
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Regulatory Partner(s) | General GMP observations |
Resonance Laboratories Private Limited No. 8C & 9A, K1ADB Industrial Area, Bashettihalli, Doddaballapur, Bangalore, India 561203 |
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Regulatory Partner(s) | General GMP observations |
Sage Products Inc. 3909 Three Oaks Road, Cary, Illinois, USA |
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Regulatory Partner(s) | General GMP observations |
Sancilio & Company Inc. 3874 Fiscal Ct Ste 200, Riviera Beach Florida, USA, 33404 |
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Regulatory Partner(s) | Data integrity General GMP observations |
Sanochemia Pharmazeutika AG Landeggerstrasse 7 Neufeld an der Leitha 2941, Austria |
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Regulatory Partner(s) | General GMP observations |
Sato Kogyo Co., Ltd 9-2, Kannonji-Cho, Kashihara City, Nara Prefecture, Japan |
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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 |
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Regulatory Partner(s) | General GMP observations |
Sekisui Medical Co., Ltd. 4-115 Matsuo, Hachimantai, Iwate Japan |
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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 |
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Regulatory Partner(s) | General GMP observations |
Shandong Xinhua Pharmaceutical Co., Ltd Hutian Chemical Industrial Zone, Zibo, Shandong, 255075, China |
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Regulatory Partner(s) | General GMP observations |
Shanghai Desano Chemical Pharmaceutical Co., Ltd. No.417 Binhai Road, Laogang Town, Pudong District, Shanghai, China |
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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 |
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Regulatory Partner(s) | General GMP observations |
Signa S.A. De C.V. 301 AV. Industria Automotriz, Zona Industrial Toluca, Toluca, Mexico, 50071, Mexico |
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Regulatory Partner(s) | General GMP observations |
SmithKline Beecham Limited Clarendon Road, Worthing, West Sussex, England, UK, BN14 8QH |
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Regulatory Partner(s) | General GMP observations |
Solara Active Pharma Sciences Limited A1/B, SIPCOT Industrial Complex, Kudikadu Village, Cuddalore, Tamil Nadu, 607 005, India |
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Regulatory Partner(s) | General GMP observations |
SpecGX LLC 100 Louis Latzer Drive, Greenville, IL, USA, 62246 |
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Regulatory Partner(s) | General GMP observations |
Spectrum Laboratory Products, Inc. 14422 South San Pedro Street Gardena, California 90248, United States |
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Regulatory Partner(s) | General GMP observations |
Spectrum Laboratory Products, Inc. 769 Jersey Avenue New Brunswick, New Jersey 08901-3605, United States |
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Regulatory Partner(s) | General GMP observations |
Sri Krishna Pharmaceuticals Ltd UNIT II A-35, IDA Nacharam Hyderabad 500 076 India |
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 |
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Regulatory Partner(s) | Data integrity General GMP observations |
Stason Pharmaceuticals Inc. 11 Morgan, Irvine, CA, 92618, United States |
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Regulatory Partner(s) | General GMP observations |
Strides Pharma Science Limited Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry |
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Regulatory Partner(s) | General GMP observations |
Svizera Laboratories Private Limited Plot D-16/6 TTC Industrial Area, MIDC Turbhe, Navi Mumbai, India |
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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 |
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Regulatory Partner(s) | General GMP observations |
Tai Heng Industry Co., Ltd., 2715 Long Wu Road, Building 2, Shanghai Juke Biotech Park, Shanghai, China 200231 |
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Regulatory Partner(s) | Data integrity General GMP observations |
Takeda Pharmaceutical Company Limited 4720 Mitsui, Hikari, Yamaguchi, 743-8502, Japan |
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Regulatory Partner(s) | General GMP observations |
Teligent Pharma US, LLC 105 Lincoln Avenue, Buena, NJ, 08310, United States |
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Regulatory Partner(s) | General GMP observations |
Tender Corporation 944 Industrial Park Rd, Littleton, New Hampshire, 03561-3956, United States |
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Regulatory Partner(s) | General GMP observations |
Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd No 1889 Jingliu Road, Linjiang Industrial Zone, Zhejiang China |
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Regulatory Partner(s) | General GMP observations |
Torrent Pharmaceuticals Limited Ahmedabad-Mehsana Highway, Taluka-Kadi, Indrad, Gujarat |
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Regulatory Partner(s) | General GMP observations |
Toyobo Co Ltd 1-1 Katata 2-chom Otsu Pharmaceuticals Plant, Otsu-shi, Siga, 520-0292, Japan |
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Regulatory Partner(s) | General GMP observations |
Tris Pharma Inc. 2033 Route 130, Monmouth Junction, NJ, 08852, United States |
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Regulatory Partner(s) | General GMP observations |
Ultra Seal Corporation 521 Main Street, New Paltz, USA |
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Regulatory Partner(s) | General GMP observations |
Ultratab Laboratories Inc., 50 Toc Drive, Highland, USA |
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Regulatory Partner(s) | General GMP observations |
UNIMARK REMEDIES LIMITED 337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District 530 049, India |
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Regulatory Partner(s) | Data Integrity |
Unimark Remedies Limited (Vapi) Plot 41/42, Phase 1 - GIDC District Valsad Pardi, Gujarat, India |
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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 |
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Regulatory Partner(s) | General GMP observations |
US Pharmaceuticals, Inc. 681 Main Street, Building 27, Belleville, New Jersey |
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Regulatory Partner(s) | General GMP observations |
USV Private Limited H-17/H-18, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman |
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Regulatory Partner(s) | Data integrity General GMP observations |
Vi-Jon LLC 8515 Page Avenue, St. Louis, MO, 63114-6014, United States |
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Regulatory Partner(s) | General GMP observations |
Vital Laboratories Pvt Ltd (Plant I) 1416-21, 1507 1 and 2 Phase III GIDC, Vapi, 396195, India |
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Regulatory Partner(s) | General GMP observations |
Vital Lab Private Limited Plant II Plot No.1710 & A1-2208, Phase III GIDC Estate, Vapi, Gujarat |
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Regulatory Partner(s) | General GMP observations |
VUAB PHARMA a.s Vltavska 53, Roztoky, CZECH REPUBLIC |
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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 |
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Regulatory Partner(s) | Data Integrity General GMP observations |
Yicheng Goto Chemical Co.Ltd. 1 Group of Gaokeng, Xiaohe, Xiaohe, Yicheng, Hebei, 441003, China |
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Regulatory Partner(s) | General GMP observations |
Yuki Gosei Kogyo Co. Ltd. 788 Ochiai, Joban Nishigo-Machi, Iwaki-Shi, Fukushima Japan, 972-8316 |
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Regulatory Partner(s) | General GMP observations |
YUNNAN HANDE BIO-TECH. Co.Ltd No. 3 Platform Jinding Tech-Zone, Kunming, Yunnan Province, China |
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Regulatory Partner(s) | Data Integrity General GMP observations |
ZHEJIANG HISOAR PHARMACEUTICAL CO. LTD. No. 100 Waisha Branch Rd, Jiaojiang, Taizhou City, Zhejiang Province CN |
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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 |
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 |
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Regulatory Partner(s) Canadian importer(s) |
Data integrity General GMP observations |
Zhejiang Hisun Pharmaceutical Co., Ltd. Inspection start date: 2019-03-26 |
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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 |
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Regulatory Partner(s) | General GMP observations |
Zhejiang Huahai Pharmaceutical Co., Ltd 104 National Road, Xunqiao, Huahai Xunqiao Site, Linhai, Zhejiang, 317 024, China |
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Regulatory Partner(s) | General GMP observations |
Zhejiang Huahai Pharmaceutical Co., Ltd. - Chuannan Site Coastal Industrial Zone, Duqiao, Linhai, Zhejiang, 317016, China |
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Regulatory Partner(s) | General GMP observations |
Zhejiang Medicine Co. Ltd Xinchang Pharmaceutical Factory, 98 East Xinchang Dadao Road, Xinchang, Zhejiang, 312500 China |
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Regulatory Partner(s) Canadian importer(s) |
Data integrity General GMP |
Zhejiang Tianyu Pharmaceutical Co. Limited Jiangkou Development Zone, Huangyan District, Taizhou, Zhejiang, 318020, China |
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Regulatory Partner(s) | General GMP observations |
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