This page includes the latest FDA filings for Genzyme 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 | 
|---|---|---|
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2025-09-24 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2025-08-21 | 
| Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc. | Prescription Medication | 2025-07-12 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2025-05-23 | 
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2025-01-12 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2025-01-01 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2024-12-13 | 
| Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc. | Prescription Medication | 2024-07-31 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2024-07-16 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2024-05-22 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2024-04-20 | 
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2024-04-06 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2024-03-19 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2024-02-24 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2024-01-13 | 
| Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2023-12-08 | 
| Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2023-11-17 | 
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-11-10 | 
| Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2023-10-19 | 
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2023-10-07 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2023-07-27 | 
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2023-06-27 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2023-05-26 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2023-05-26 | 
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2023-05-12 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2023-05-05 | 
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2023-01-19 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2023-01-12 | 
| Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2022-12-21 | 
| Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc. | Prescription Medication | 2022-12-17 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2022-12-17 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2022-11-22 | 
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2022-11-03 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2022-11-01 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2022-10-01 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2022-08-25 | 
| Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2022-07-30 | 
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2022-06-03 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2022-06-03 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2022-05-26 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2022-05-03 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2022-04-07 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2022-01-22 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2022-01-05 | 
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2021-12-07 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2021-11-20 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2021-08-25 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2021-08-17 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2021-08-17 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2021-08-04 | 
| Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc. | Prescription Medication | 2021-07-16 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2021-07-14 | 
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2021-07-14 | 
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2021-07-14 | 
| Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2021-05-27 | 
| Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2021-05-22 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2021-05-08 | 
| Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc. | Prescription Medication | 2021-05-07 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | 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, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2021-03-12 | 
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2021-03-02 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2021-01-30 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2020-12-12 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2020-12-10 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2020-12-02 | 
| Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2020-10-17 | 
| Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2020-10-16 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2020-10-06 | 
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2020-08-25 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2020-07-09 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2020-06-23 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2020-06-04 | 
| Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc. | Prescription Medication | 2020-05-14 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2020-04-01 | 
| 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 | 
| Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2020-01-03 | 
| Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2020-01-03 | 
| Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc. | Prescription Medication | 2019-12-17 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2019-12-05 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2019-11-20 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2019-11-06 | 
| Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Pharmachem Testing Services, Ash Stevens Inc., Genzyme Limited, Genzyme Corporation | Prescription Medication | 2019-10-25 | 
| Winthrop U.S, a business of sanofi-aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma International Pty Ltd., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2019-10-25 | 
| Sanofi-Aventis U.S. LLC, Pharmachemie B.V., Pfanstiehl, Inc., Mayne Pharma Inc., Ash Stevens Inc., EUROAPI UK LIMITED, Genzyme Corporation | Prescription Medication | 2019-10-25 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2019-08-08 | 
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2019-06-18 | 
| Genzyme Corporation, Genzyme Flanders, Genzyme Ireland Limited, Genzyme Limited, Eurofins Biopharma Product Testing Ireland Limited | Prescription Medication | 2019-06-07 | 
| sanofi-aventis  U.S. LLC, Aptuit (Oxford) Ltd, Genzyme Corporation | Prescription Medication | 2019-06-07 | 
| Winthrop U.S., Genzyme Corporation, Genzyme Ireland Limited, Reed-Lane, Inc. | Prescription Medication | 2019-03-22 | 
| Genzyme Corporation, Boehringer Ingelheim Pharma GmbH & Co. KG, Sanofi-Aventis Deutschland GmbH, EUROAPI UK LIMITED | Prescription Medication | 2018-12-15 | 
| Genzyme Corporation, Lonza AG, IPR Pharmaceuticals, Inc, Penn Pharmaceutical Services Limited, AstraZeneca UK Ltd, AstraZeneca Pharmaceuticals LP, EUROAPI UK LIMITED | Prescription Medication | 2018-11-30 | 
| Genzyme Corporation, Genzyme Limited, Genzyme Ireland Limited, Lonza Biologics, Inc. | Prescription Medication | 2018-04-20 |