8/20/2022 3012163998 Hugel Inc. 483 Korea (Republic of) 9/6/2022 8/12/2022 3002807979 Sun Pharmaceuticals Industries Limited 483 India 8/18/2022 7/15/2022 3007772056 Revance Therapeutics 483 USA 8/18/2022 7/1/2022 3008581988 Cipla Limited 483 India 8/17/2022 2/15/2022 1000291122 Rentschler Biopharma SE 483 Germany 6/10/2022 2/4/2022 1000418405 Bioiberica, S.A.U 483 Spain 6/9/2022 5/10/2022 300737352 Aurobindo Pharma Ltd. 483 India 5/24/2022 3/30/2022 3006271438 Novel Laboratories Inc. d.b.a. Lupin Somerset 483 USA 5/16/2022 5/9/2022 3002809586 Sun Pharmaceutical Industries, Halol, India 483 India 5/13/2022 9/2/2020 3005949964 Catalent Biologics 483 U.S. 4/4/2022 8/11/2017 3007719313 Zhejiang Hisun Pharmaceuticals 483 China 3/29/2022 1/19/2017 3007719313 Zhejiang Hisun Pharmaceuticals 483 China 3/29/2022 3/10/2022 3013712903 Cadila Healthcare Limited 483 India 3/18/2022 4/2/2021 3010606982 Wuxi Biologics 483 China 3/15/2022 4/16/2019 3010606982 Wuxi Biologics 483 China 3/15/2022 9/13/2019 3003153579 Emergent BioSolutions Canada Inc. 483 Canada 1/25/2022 9/13/2019 3003153579 Emergent BioSolutions Canada Inc. EIR Canada 1/25/2022 10/26/2021 3007647000 Catalent Brussels 483 Belgium 1/14/2022 10/29/2021 3006549835 Dr. Reddy's Laboratories Ltd. 483 India 12/6/2021 7/2/2021 3007772056 Revance Therapeutic, Inc. SEIR USA 11/18/2021 9/24/2021 3011248248 Biocon Sdn. Bhd. 483 Malaysia 10/25/2021 7/2/2021 3007772056 Revance Therapeutics, Inc. 483 USA 10/12/2021 2/21/2021 1000251214 Toyobo Co. 483 Japan 9/3/2021 4/21/2021 3000718852 Fujifilm Diosynth Biotechnologies USA 483 USA 8/26/2021 8/12/2021 3004021253 Aurobindo Pharma Limited Unit 1 483 India 8/24/2021 3/12/2021 3006895982 Jubilant Generics Limited 483 India  8/17/2021 7/27/2021   Amazon.com, Inc. Untitled Letter United States 7/27/2021 2/25/2020 3009876430 Shilpa Medicare Ltd. 483 India 4/2/2020 3/5/2020 3005447965 Dr. Reddy's Laboratories CTO 5 483 India 4/2/2020 2/21/2020 3011248248 Biocon Sdn Bhd 483 Malaysia 4/2/2020 3/10/2020 1000526871 Immunomedics Inc. 483 USA 4/2/2020 1/24/2020 3010164491 Biocon Ltd. 483 India 3/6/2020 1/28/2020 3002949085 Dr. Reddy's Laboratories Limited CTO Unit VI 483 India 2/5/2020 1/17/2020 3013127166 Lupin Limited 483 India 2/4/2020 12/13/2019 3002809586 Sun Pharmaceutical Industries Ltd. 483 India 12/20/2019 10/25/2019 3004086884 Aurobindo Pharma Ltd. Unit 8 483 India 11/20/3029 10/28/2019 3004051616 Aurobindo Pharma Ltd. Unit 5 483 India 11/20/2019 9/27/2019 3004081307 Cipla Limited 483 India 10/11/2019 9/27/2019 3007373532 Aurobindo Pharma Ltd. 483 India 10/9/2019 9/20/2019 3002807512 Lupin Limited 483 India 10/9/2019 8/23/2019 3005977675 Ipca Laboratories Limited 483 India 9/10/2019 8/20/2019 3006549835 Dr. Reddy's Laboratories Ltd. 483 India 8/29/2019 7/26/2019 3007197995 Shilpa Medicare Limited 483 India 8/22/2019 7/12/2019 3005448030 Dr. Reddy's Laboratories Ltd. Unit II 483 India 7/30/2019 7/19/2019 3002806691 Cipla Ltd. Virgonagar Site 483 India 7/30/2019 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

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