U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. CDER FOIA Electronic Reading Room
  5. Frequently requested or proactively posted compliance records
  1. Guidance, Compliance, & Regulatory Information

Frequently requested or proactively posted compliance records

Frequently requested or proactively posted compliance records

Record Date FEI Number Firm Name Record Type Country Date Posted
6/4/2019 3005124189 Indoco Remedies Limited 483 India 7/9/2019
6/21/2019 3006549835 Dr. Reddy's Laboratories Ltd. 483 India 7/9/2019
6/11/2019 3002809586 Sun Pharmaceutical Industries Ltd. 483 Halol, Gujarat, India 6/21/2019
5/24/2019 3004021229 Aurobindo Pharma Ltd. Telangana 483 India 6/10/2019
5/15/2019 3004995645 Lupin Limited 483 India 5/22/2019
5/3/2019 3002984011 Cadila Healthcare Ltd. 483 India 5/14/2019
4/16/2019 3005029956 Torrent Pharmaceuticals Ltd. 483 India 5/2/2019
8/14/2018 1000526871 Immunomedics EIR United States 4/29/2019
3/1/2019 3011905047 Aurobindo Pharma Limited Unit 16 483 India 4/8/2019
2/5/2019 3002957541 Sun Pharmaceutical Medicare Limited 483 India 3/22/2019
2/15/2019 3003981475 Biocon 483 India 3/12/2019
1/15/2019 3009193040 Dr. Reddy’s Laboratories Ltd. 483 India 2/26/2019
12/14/2018 3008461619 Aurobindo Pharma Limited - Unit IV 483 India 2/25/2019
2/8/2019 3004819820 Lupin Limited 483 India 2/19/2019
2/8/2019 3002949099 Dr. Reddy’s Laboratories 483 India 2/19/2019
1/25/2019 3006644152 Indoco Remedies 483 India 2/12/2019
8/14/2018 1000526871 Immunomedics, Inc. 483 USA 2/12/2019
1/25/2019 3007549629 Lupin Ltd. 483 India 2/8/2019
4/3/2018 3008386908 Hospira Healthcare India 483 India 7/11/2018
9/14/2016 3005587313 Mylan Laboratories Ltd. 483 India 6/26/2018
3/30/2018 3004879807 Galaxy Surfactants Ltd. 483 India 6/26/2018
3/23/2018 3010166890 Galaxy Surfactants Ltd. 483 India 6/26/2018
5/24/2018 3008565058 Glenmark Pharmaceuticals Ltd. 483 India 6/5/2018
3/6/2018 3009883410 Auronext Pharma 483 India 5/17/2018
5/1/2018 3003981475 Biocon Ltd. 483 India 5/17/2018
5/25/2016 3005531475 Akorn AG 483 Switzerland 5/7/2018
12/12/2017 3005531475 Akorn AG 483 Switzerland 5/3/2018
2/15/2018 1000623515 Suven Life Sciences Ltd. 483 India 4/24/2018
4/13/2018 3008581988 Cipla Ltd. 483 India 4/20/2018
6/2/2017 3005241015 Celltrion Inc. 483 Republic of Korea 4/12/2018
3/27/2018 3006370524 Alkem Laboratories Ltd. 483 India 4/11/2018
3/20/2018 3004956904 Alembic Pharmaceuticals Ltd. 483 India 4/10/2018
6/2/2017 3005241015 Celltrion Inc. EIR Korea (the Republic of) 3/30/2018
1/25/2018 3004081307 Cipla Ltd. 483 India 3/27/2018
3/9/2018 3003184497 Dr. Reddy's Laboratories Ltd. 483 India 3/21/2018
2/15/2018 3011248248 Biocon Sdn Bhd 483 Malaysia 3/12/2018
2/23/2018 3002809586 Sun Pharmaceutical Industries Ltd. 483 India 3/6/2018
2/20/2018 3008461619 Aurobindo Pharma Ltd. 483 India 3/6/2018
1/20/2017 3002806462 Bayer AG Pharma 483 Germany 2/22/2018
1/19/2018 3006644152 Indoco Remedies 483 India 2/15/2018
1/19/2018 3007197995 Shilpa Medicare 483 India 1/30/2018
11/17/2017 3012333115 Daewoong Pharmaceutical Co. Ltd. 483 Republic of Korea 1/22/2018
3/8/2017 3006549835 Dr. Reddy's Laboratories Unit 7 EIR India 1/3/2018
11/30/2017 3009876430 Shilpa Medicare Limited 483 India 12/8/2017
11/11/2017 3005757050 Glenmark Pharmaceuticals Ltd. 483 India 12/5/2017
8/4/2017 3004610460 Claris Injectables Ltd. 483 India 10/19/2017
9/19/2017 3004149463 Divi's Laboratories Ltd. Unit II 483 India 9/26/2017
9/1/2017 3004021263 Aurobindo Pharma Ltd. Unit VI 483 India 9/26/2017
9/15/2017 3002807544 Dr. Reddy's Laboratories (EU) Ltd. 483 United Kingdom 9/26/2017
6/2/2017 3003981475 Biocon Ltd. 483 India 8/3/2017
5/10/2017 3007277149 Intas Pharmaceuticals 483 India 7/19/2017
8/17/2016 3010671506 Zhejiang Bangli Medical Products Co. 483 China 7/7/2017
6/16/2017 3009107538 Lupin Limited Unit III 483 India 6/29/2017
6/16/2017 3009193040 Dr. Reddy's Laboratories Unit 1 483 India 6/29/2017
5/26/2017 3004554612 Strides Shasun Limited 483 India 6/5/2017
5/19/2017 3007549629 Lupin Limited 483 India 6/2/2017
6/17/2016 3002806840 Sekisui Medical 483 Japan 5/16/2017
4/28/2017 3005029956 Torrent Pharmaceuticals Limited 483 India 5/11/2017
8/19/2016 3004058356 Badrivishal Chemicals & Pharmaceuticals 483 India 5/11/2017
1/15/2016 3002806754 Cosma SpA 483 Italy 5/11/2017
7/1/2016 3004086884 Aurobindo Pharma Limited Unit 8 483 India 5/11/2017
4/7/2017 3003981475 Biocon Limited 483 India 5/9/2017
4/28/2017 3008461619 Aurobindo Pharma Ltd. Unit IV 483 India 5/8/2017
4/28/2017 3002949099 Dr. Reddy's Laboratories 483 India 5/4/2017
4/18/2017 3004021229 Aurobindo Pharm Ltd. Unit 3 483 India 5/2/2017
4/7/2017 3004819820 Lupin Limited 483 India 4/27/2017
4/4/2017 3002949085 Dr. Reddy's Laboratories Unit 6 483 India 4/25/2017
4/7/2017 3006230648 Marksans Pharma Ltd. 483 India 4/25/2017
4/13/2017 3004561553 Sun Pharmaceutical Industries Ltd. 483 India 4/21/2017
3/10/2017 3006370533 Alkem Laboratories Limited 483 India 3/28/2017
3/8/2017 3005430968 Dr. Reddy's Laboratories 483 India 3/21/2017
3/1/2017 3005430968 Cadila Healthcare Limited 483 India 3/15/2017
2/21/2017 3005447965 Dr. Reddy's Laboratories 483 India 2/21/2017
1/24/2017 3004540906 Natco Pharma Limited 483 India 2/1/2017
10/13/2015 3003369660 CP Pharmaceuticals 483 United Kingdom 1/27/2017
12/15/2015 3002808500 Wockhardt Limited 483 India 1/26/2017
12/16/2016 3008307735 Hetero Labs Limited 483 India 1/13/2017
12/9/2016 3012806860 Granules 483 India 1/10/2017
10/25/2016 3004021253 Aurobindo Pharma Unit 1, Telangana 483 India 1/6/2017
12/6/2016 3004149463 Divi's Laboratories 483 India 12/28/2016
6/18/2015 3003631275 Zhejiang Medicine Co. 483 China 12/15/2016
9/16/2016 3008461619 Aurobindo Pharma Limited Unit 4 483 India 12/15/2016
12/1/2016 3002809586 Sun Pharmaceutical Industries Ltd. 483 India 12/13/2016
11/16/2016 3002807979 Sun Pharmaceuticals Industries, Inc. 483 India 11/29/2016
9/29/2016 3006370524 Alkem Laboratories Limited 483 India 11/29/2016
9/4/2016 3005124189 Indoco Remedies Limited 483 India 11/29/2016
8/30/2016 3004081307 Cipla Limited 483 India 11/29/2016
8/26/2016 3004610460 Claris Injectables Limited 483 India 11/29/2016
7/19/2016 3003259844 Sanofi Winthrop Industrie 483 France 11/29/2016
7/17/2016 3004819820 Lupin Limited 483 India 11/29/2016
7/6/2016 3005906909 Lupin Limited 483 India 11/29/2016
3/25/2016 3004956904 Alembic Pharmaceuticals Limited 483 India 11/29/2016
1/29/2016 3002875215 Teva Pharmaceutical Works Private Limited Company 483 Hungary 11/29/2016
11/18/2016 3003999190 Zhejiang Huahai Pharmaceutical Co. Ltd. 483 China 8/9/2018
5/19/2017 3003885745 Zhejiang Huahai Pharmaceutical Co. Ltd. 483 China 8/9/2018
11/17/2017 3002808534 Yuki Gosei Kogyo Co. Ltd. 483 Japan 9/10/2018
3/2/2018 3003510514 Hetero Drugs Ltd. Unit 1 483 India 7/17/2018
5/1/2018 3005949964 Cook Pharmica LLC 483 United States 9/10/2018
7/17/2018 3005241015 Celltrion Inc. 483 South Korea 8/6/2018
7/27/2018 3006456888 Unichem Laboratories Ltd. 483 India 9/10/2018
8/3/2018 3003885745 Zhejiang Huahai Pharmaceutical Co. Ltd. 483 China 9/20/2018
8/24/2018 3004554612 Strides Pharma Science Ltd. 483 India 9/26/2018
8/28/2018 3013712903 Liva Pharmaceuticals Ltd. 483 India 9/10/2018
8/31/2018 3002809586 Sun Pharmaceutical Industries Ltd. 483 India 9/10/2018
9/14/2018 3002807979 Sun Pharmaceutical Industries Ltd. 483 India 9/24/2018
9/28/2018 3004081307 Cipla Limited 483 India 10/22/2018
10/16/2018 3011566408 Gadea Biopharma S.L. 483 Leon, Spain 12/4/2018
10/18/2018 3009107538 Lupin Limited – Unit 3 483 India 11/5/2018
10/26/2018 3004161218 Dishman Carbogen Amcis Ltd. 483 India 12/10/2018
10/30/2018 3006549835 Dr. Reddy’s Laboratories Ltd. 483 India 11/14/2018