This page includes the latest FDA filings for Bioreliance L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
| CELLTRION USA, Inc., CELLTRION Inc., BioReliance Ltd, BioReliance Ltd., WuXi Advanced Therapies, Inc, Samsung Biologics Co., Ltd., Patheon Italia S.p.A., STERIPACK MEDICAL POLAND SP Z O O, CELLTRION Pharm, Inc., Sterigenics Belgium Petit Rechain SA, Sterigenics Germ | Prescription Medication | 2025-11-12 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2025-11-11 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2025-10-05 |
| Bio-Thera Solutions, Ltd., BioReliance Ltd., WuXi Biologics (Suzhou) Co. Ltd. | Prescription Medication | 2025-10-03 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2025-09-13 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2025-09-10 |
| Incyte Corporation, MILLMOUNT HEALTHCARE LIMITED | Prescription Medication | 2025-07-10 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2025-06-30 |
| CELLTRION USA Inc., CELLTRION Inc., BioReliance Ltd., Wuxi Advanced Therapies, Inc., WuXi AppTec, Inc., SGS Vitrology Limited, VETTER Pharma-Fertigung GmbH & Co. KG, CELLTRION Pharm, Inc., KYMOS, S.L. | Prescription Medication | 2025-05-30 |
| CELLTRION USA Inc., CELLTRION Inc., BioReliance Ltd., Wuxi Advanced Therapies, Inc., WuXi AppTec, Inc., SGS Vitrology Limited, VETTER Pharma-Fertigung GmbH & Co. KG, CELLTRION Pharm, Inc., KYMOS, S.L. | Prescription Medication | 2025-05-19 |
| CELLTRION USA Inc., CELLTRION Inc., BioReliance Ltd., Wuxi Advanced Therapies, Inc., WuXi AppTec, Inc., SGS Vitrology Limited, VETTER Pharma-Fertigung GmbH & Co. KG, CELLTRION Pharm, Inc., KYMOS, S.L. | Prescription Medication | 2025-05-15 |
| CELLRION USA, Inc., CELLTRION Inc., BioReliance Ltd., Samsung Biologics, CELLTRION PHARM Inc. | Prescription Medication | 2025-05-10 |
| CELLTRION Inc., BioReliance Ltd, WuXi Advanced Therapies, Inc, Samsung Biologics Co., Ltd., CELLTRION Pharm, Inc., Patheon Italia S.p.A., KYMOS, S.L., STERIPACK MEDICAL POLAND SP Z O O | Prescription Medication | 2025-04-22 |
| Cephalon, Inc., CELLTRION, Inc., WuXi AppTec, Inc., BioReliance Ltd., Andersonbrecon Inc., Andersonbrecon Limited | Prescription Medication | 2025-04-19 |
| CELLTRION Inc., BioReliance Ltd, WuXi Advanced Therapies, Inc, Samsung Biologics Co., Ltd., CELLTRION Pharm, Inc., Patheon Italia S.p.A., KYMOS, S.L., STERIPACK MEDICAL POLAND SP Z O O | Prescription Medication | 2025-03-16 |
| CELLTRION Inc., BioReliance Ltd, WuXi Advanced Therapies, Inc, Samsung Biologics Co., Ltd., CELLTRION Pharm, Inc., Patheon Italia S.p.A., KYMOS, S.L., STERIPACK MEDICAL POLAND SP Z O O | Prescription Medication | 2025-03-04 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2025-02-23 |
| Cephalon, Inc., CELLTRION, Inc., WuXi AppTec, Inc., BioReliance Ltd., Andersonbrecon Inc., Andersonbrecon Limited | Prescription Medication | 2025-02-15 |
| Cephalon, Inc., CELLTRION, Inc., WuXi AppTec, Inc., BioReliance Ltd., Andersonbrecon Inc., Andersonbrecon Limited | Prescription Medication | 2025-01-12 |
| Bio-Thera Solutions, Ltd., BioReliance Ltd., WuXi Biologics (Suzhou) Co. Ltd. | Prescription Medication | 2025-01-01 |
| CELLTRION Inc., BioReliance Ltd, WuXi Advanced Therapies, Inc, Samsung Biologics Co., Ltd., CELLTRION Pharm, Inc., Patheon Italia S.p.A., KYMOS, S.L., STERIPACK MEDICAL POLAND SP Z O O | Prescription Medication | 2024-12-28 |
| Cephalon, Inc., CELLTRION, Inc., WuXi AppTec, Inc., BioReliance Ltd., Andersonbrecon Inc., Andersonbrecon Limited | Prescription Medication | 2024-11-27 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2024-11-15 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2024-10-24 |
| Incyte Corporation, MILLMOUNT HEALTHCARE LIMITED | Prescription Medication | 2024-10-16 |
| TAKEDA PHARMACEUTICALS AMERICA, INC., Takeda Manufacturing Singapore Pte Ltd, Takeda Manufacturing Austria AG, SGS Lab Simon, BioReliance Ltd, Sigma-Aldrich Pte Ltd, Shire Human Genetic Therapies Inc., Charles River Laboratories Germany GmbH, OFI Technologie & Inn | Prescription Medication | 2024-08-31 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2024-08-30 |
| TAKEDA PHARMACEUTICALS AMERICA, INC., Takeda Manufacturing Singapore Pte Ltd, Takeda Manufacturing Austria AG, SGS Lab Simon, BioReliance Ltd, Sigma-Aldrich Pte Ltd, Shire Human Genetic Therapies Inc., Charles River Laboratories Germany GmbH, OFI Technologie & Inn | Prescription Medication | 2024-08-23 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2024-08-06 |
| CELLTRION USA Inc., CELLTRION Inc., BioReliance Ltd., Wuxi Advanced Therapies, Inc., WuXi AppTec, Inc., SGS Vitrology Limited, VETTER Pharma-Fertigung GmbH & Co. KG, CELLTRION Pharm, Inc., KYMOS, S.L. | Prescription Medication | 2024-07-30 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2024-07-24 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2024-06-28 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2024-06-01 |
| CELLTRION USA Inc., CELLTRION Inc., BioReliance Ltd., Wuxi Advanced Therapies, Inc., WuXi AppTec, Inc., SGS Vitrology Limited, VETTER Pharma-Fertigung GmbH & Co. KG, CELLTRION Pharm, Inc., KYMOS, S.L. | Prescription Medication | 2024-05-04 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2024-04-06 |
| CELLTRION USA Inc., CELLTRION Inc., BioReliance Ltd., Wuxi Advanced Therapies, Inc., WuXi AppTec, Inc., SGS Vitrology Limited, VETTER Pharma-Fertigung GmbH & Co. KG, CELLTRION Pharm, Inc., KYMOS, S.L. | Prescription Medication | 2024-03-01 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2023-12-23 |
| TAKEDA PHARMACEUTICALS AMERICA, INC., Takeda Manufacturing Singapore Pte Ltd, Takeda Manufacturing Austria AG, SGS Lab Simon, BioReliance Ltd, Sigma-Aldrich Pte Ltd, Shire Human Genetic Therapies Inc., Charles River Laboratories Germany GmbH, OFI Technologie & Inn | Prescription Medication | 2023-11-23 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2023-10-30 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2023-09-21 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2023-08-08 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2023-07-26 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2023-07-19 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2023-06-30 |
| Incyte Corporation, MILLMOUNT HEALTHCARE LIMITED | Prescription Medication | 2023-06-25 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2023-05-06 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2023-04-21 |
| CELLRION USA, Inc., CELLTRION Inc., BioReliance Ltd., Samsung Biologics, CELLTRION PHARM Inc. | Prescription Medication | 2023-04-03 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2023-03-01 |
| Cephalon, Inc., CELLTRION, Inc., WuXi AppTec, Inc., BioReliance Ltd., Andersonbrecon Inc., Andersonbrecon Limited | Prescription Medication | 2023-02-25 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2023-02-17 |
| CELLRION USA, Inc., CELLTRION Inc., BioReliance Ltd., Samsung Biologics, CELLTRION PHARM Inc. | Prescription Medication | 2023-01-29 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2022-12-23 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2022-12-17 |
| Incyte Corporation, MILLMOUNT HEALTHCARE LIMITED | Prescription Medication | 2022-12-03 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2022-11-29 |
| Cephalon, Inc., CELLTRION, Inc., WuXi AppTec, Inc., BioReliance Ltd., Andersonbrecon Inc., Andersonbrecon Limited | Prescription Medication | 2022-11-03 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2022-09-14 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2022-09-10 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2022-08-31 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2022-04-26 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2022-02-18 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2022-01-26 |
| Cephalon, Inc., CELLTRION, Inc., WuXi AppTec, Inc., BioReliance Ltd., Andersonbrecon Inc., Andersonbrecon Limited | Prescription Medication | 2021-12-31 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2021-11-16 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2021-11-09 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2021-08-20 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2021-07-03 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2021-06-19 |
| Incyte Corporation, MILLMOUNT HEALTHCARE LIMITED | Prescription Medication | 2021-06-08 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2021-04-14 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2021-03-20 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2020-12-24 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2020-12-18 |
| Incyte Corporation, MILLMOUNT HEALTHCARE LIMITED | Prescription Medication | 2020-09-10 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2020-08-18 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2020-08-15 |
| Incyte Corporation, MILLMOUNT HEALTHCARE LIMITED | Prescription Medication | 2020-08-05 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2020-04-11 |
| Cephalon, Inc., CELLTRION, Inc., WuXi AppTec, Inc., BioReliance Ltd., Andersonbrecon Inc., Andersonbrecon Limited | Prescription Medication | 2020-03-19 |
| Horizon Therapeutics USA, Inc., Patheon Italia S.p.A. | Prescription Medication | 2020-01-31 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2020-01-18 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2019-11-01 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2019-08-16 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2019-07-26 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2019-07-10 |
| Biogen Inc., Packaging Coordinators, LLC | Prescription Medication | 2019-06-29 |
| Cephalon, Inc., CELLTRION, Inc., WuXi AppTec, Inc., BioReliance Ltd., Andersonbrecon Inc., Andersonbrecon Limited | Prescription Medication | 2019-05-30 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2019-05-22 |
| Regeneron Pharmaceuticals, Inc., Vetter Pharma-Fertigung GmbH & Co. KG, Sharp Packaging Services, LLC, Baxter Pharmaceutical Solutions, LLC, Nelson Laboratories, Eurofins Lancaster Laboratories, Inc, Catalent Indiana, LLC, Packaging Coordinators, LLC, Eurofins Bio | Prescription Medication | 2019-05-17 |
| Pfizer Laboratories Div Pfizer Inc, CELLTRION, Inc., Hospira Zagreb d.o.o., Bioreliance Ltd., Pharmacia & Upjohn Company LLC, BioReliance Corporation | Prescription Medication | 2019-04-10 |