This page includes the latest FDA filings for Eurofins Biopharma Product Testing Ireland 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 |
|---|---|---|
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2025-09-10 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2025-09-05 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2025-08-31 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2025-08-24 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2025-07-23 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2025-07-02 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2025-06-08 |
| Genzyme Corporation, Bionique Testing Laboratories, Inc., Bioreliance Corporation, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2025-03-06 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2025-02-13 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2025-02-09 |
| Genzyme Corporation, Bionique Testing Laboratories, Inc., Bioreliance Corporation, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2025-02-09 |
| NextSource Pharma, Eirgen Pharma Ltd, Eurofins Biopharma Product Testing Ireland Limited, Quinta-Analytica s.r.o., Hetero Labs Limited, Valary Lab Private Limited, Analys Lab Private Limited, TEENA BIOLABS PRIVATE LIMITED | Prescription Medication | 2025-01-20 |
| NextSource Pharma, Eirgen Pharma Ltd, Eurofins Biopharma Product Testing Ireland Limited, Quinta-Analytica s.r.o., Hetero Labs Limited, Valary Lab Private Limited, Analys Lab Private Limited, TEENA BIOLABS PRIVATE LIMITED | Prescription Medication | 2025-01-17 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2025-01-12 |
| Genzyme Corporation, Bionique Testing Laboratories, Inc., Bioreliance Corporation, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2024-10-11 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2024-09-18 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2024-08-23 |
| Bioverativ Therapeutics Inc., Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse), Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse), Eurofins Biopharma Product Testing Munich GmbH, Vetter Pharma Fertigung GmbH & Co. KG (Rave | Other Medication | 2024-05-17 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2024-05-04 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2024-04-06 |
| Regeneron Pharmaceuticals, Inc., Sanofi Chimie, Regeneron Ireland Unlimited Company (Raheen), Sanofi-Aventis Deutschland GmbH, Genzyme Ireland Limited, Sanofi Winthrop Industrie, Eurofins BioPharma Product Testing Munich GmBH, Eurofins BioPharma Product Testing I | Prescription Medication | 2024-04-05 |
| Genzyme Corporation, Bionique Testing Laboratories, Inc., Bioreliance Corporation, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-12-13 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2023-12-08 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-11-10 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2023-10-06 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-09-27 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2023-09-26 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2023-09-13 |
| Moderna US, Inc., ModernaTX, Inc., Rovi Pharma Industrial Services S.A., Catalent Anagni S.R.L., MODERNA BIOTECH SPAIN SL., Associates of Cape Cod, Eurofins Lancaster Laboratories, LLC, Eurofins Biopharma Product Testing Ireland Limited | Other Medication | 2023-09-01 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2023-08-18 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2023-08-17 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2023-07-31 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2023-07-31 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2023-07-14 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2023-07-14 |
| Genzyme Corporation, Bionique Testing Laboratories, Inc., Bioreliance Corporation, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-07-08 |
| Genzyme Corporation, EUROAPI UK LIMITED, Genzyme Ireland Limited, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-06-23 |
| Bioverativ Therapeutics Inc., Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse), Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse), Eurofins Biopharma Product Testing Munich GmbH, Vetter Pharma Fertigung GmbH & Co. KG (Rave | Other Medication | 2023-06-03 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2023-05-18 |
| Genzyme Corporation, EUROAPI UK LIMITED, Genzyme Ireland Limited, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-05-18 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-05-12 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-04-21 |
| Genzyme Corporation, Bionique Testing Laboratories, Inc., Bioreliance Corporation, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-04-12 |
| Genzyme Corporation, EUROAPI UK LIMITED, Genzyme Ireland Limited, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2022-12-17 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2022-11-19 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2022-11-19 |
| Genzyme Corporation, Bionique Testing Laboratories, Inc., Bioreliance Corporation, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2022-09-03 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2022-06-03 |
| Bioverativ Therapeutics Inc., Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse), Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse), Eurofins Biopharma Product Testing Munich GmbH, Vetter Pharma Fertigung GmbH & Co. KG (Rave | Other Medication | 2022-02-05 |
| Genzyme Corporation, EUROAPI UK LIMITED, Genzyme Ireland Limited, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2021-08-20 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2021-08-10 |
| Bioverativ Therapeutics Inc., Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse), Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse), Eurofins Biopharma Product Testing Munich GmbH, Vetter Pharma Fertigung GmbH & Co. KG (Rave | Other Medication | 2021-08-03 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2021-07-16 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2021-07-16 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2021-07-14 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2021-05-07 |
| Genzyme Corporation, EUROAPI UK LIMITED, Genzyme Ireland Limited, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2021-05-07 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2021-05-07 |
| Regeneron Pharmaceuticals, Inc., Sanofi Chimie, Regeneron Ireland Unlimited Company (Raheen), Sanofi-Aventis Deutschland GmbH, Genzyme Ireland Limited, Sanofi Winthrop Industrie, Eurofins BioPharma Product Testing Munich GmBH, Eurofins BioPharma Product Testing I | Prescription Medication | 2021-04-09 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2021-03-31 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2021-03-02 |
| Regeneron Pharmaceuticals, Inc., Sanofi Chimie, Regeneron Ireland Unlimited Company (Raheen), Sanofi-Aventis Deutschland GmbH, Genzyme Ireland Limited, Sanofi Winthrop Industrie, Eurofins BioPharma Product Testing Munich GmBH, Eurofins BioPharma Product Testing I | Prescription Medication | 2020-11-26 |
| Bioverativ Therapeutics Inc., Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse), Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse), Eurofins Biopharma Product Testing Munich GmbH, Vetter Pharma Fertigung GmbH & Co. KG (Rave | Other Medication | 2020-11-06 |
| Regeneron Pharmaceuticals, Inc., Sanofi Chimie, Regeneron Ireland Unlimited Company (Raheen), Sanofi-Aventis Deutschland GmbH, Genzyme Ireland Limited, Sanofi Winthrop Industrie, Eurofins BioPharma Product Testing Munich GmBH, Eurofins BioPharma Product Testing I | Prescription Medication | 2020-09-12 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2020-06-13 |
| Regeneron Pharmaceuticals, Inc., Sanofi Chimie, Regeneron Ireland Unlimited Company (Raheen), Sanofi-Aventis Deutschland GmbH, Genzyme Ireland Limited, Sanofi Winthrop Industrie, Eurofins BioPharma Product Testing Munich GmBH, Eurofins BioPharma Product Testing I | Prescription Medication | 2020-06-11 |
| Regeneron Pharmaceuticals, Inc., Sanofi Chimie, Regeneron Ireland Unlimited Company (Raheen), Sanofi-Aventis Deutschland GmbH, Genzyme Ireland Limited, Sanofi Winthrop Industrie, Eurofins BioPharma Product Testing Munich GmBH, Eurofins BioPharma Product Testing I | Prescription Medication | 2020-06-09 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2020-06-09 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2020-05-14 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2020-05-14 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2020-05-08 |
| Genzyme Corporation, EUROAPI UK LIMITED, Genzyme Ireland Limited, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2020-05-08 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2020-02-27 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2020-02-22 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2019-12-10 |
| Bioverativ Therapeutics Inc., Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse), Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse), Eurofins Biopharma Product Testing Munich GmbH, Vetter Pharma Fertigung GmbH & Co. KG (Rave | Other Medication | 2019-11-20 |
| Bioverativ Therapeutics Inc., Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse), Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse), Eurofins Biopharma Product Testing Munich GmbH, Vetter Pharma Fertigung GmbH & Co. KG (Rave | Other Medication | 2019-07-24 |
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2019-06-07 |
| Genzyme Corporation, EUROAPI UK LIMITED, Genzyme Ireland Limited, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2019-02-28 |
| Winthrop U.S., Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Rovi Pharma Industrial Services SA | Prescription Medication | 2018-10-20 |
| Genzyme Corporation, Genzyme Ireland Limited, EUROAPI UK LIMITED, Reed-Lane, Inc., Eurofins Biopharma Product Testing Ireland Limited, Sanofi Winthrop Industrie, Rovi Pharma Industrial Services SA | Prescription Medication | 2018-10-18 |