This page includes the latest FDA filings for Cangene Biopharma L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2025-08-02 |
| Nexus Pharmaceuticals LLC | Prescription Medication | 2025-07-18 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2025-06-18 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2025-06-01 |
| Bausch Health US LLC, Cangene bioPharma LLC | Prescription Medication | 2025-04-10 |
| Bausch Health US LLC, Cangene bioPharma LLC | Prescription Medication | 2025-03-03 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2025-01-09 |
| Medicure International Inc, Baxter Healthcare Corporation, Cangene BioPharma, LLC, Laboratorios Grifols, S.A. | Prescription Medication | 2024-12-26 |
| Medicure International Inc, Laboratorios Grifols, S.A. | Prescription Medication | 2024-12-26 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2024-12-20 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2024-12-13 |
| Nexus Pharmaceuticals LLC | Prescription Medication | 2024-12-08 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2024-12-08 |
| La Jolla Pharmaceutical Company, Bora Pharmaceuticals Injectables Inc. | Prescription Medication | 2024-11-27 |
| BTG International Inc., Cangene BioPharma, LLC | Other Medication | 2024-11-20 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2024-11-05 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2024-10-27 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2024-08-22 |
| Cenexi HSC, Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, Inc., Eurofins Advantar Laboratories, Inc., Cangene BioPharma, LLC, Nelson Laboratories, LLC, AndersonBrecon Inc | Prescription Medication | 2024-08-09 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2024-07-19 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2024-07-13 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2024-07-04 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2024-07-04 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2024-06-27 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2024-06-19 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2024-03-20 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2024-02-17 |
| Sedor Pharmaceuticals, LLC, Cangene BioPharma, LLC | Prescription Medication | 2023-12-15 |
| Medicure International Inc, Baxter Healthcare Corporation, Cangene BioPharma, LLC, Laboratorios Grifols, S.A. | Prescription Medication | 2023-11-18 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2023-11-02 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2023-10-30 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2023-10-12 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2023-08-02 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2023-06-08 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2023-06-03 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2023-06-01 |
| Medicure International Inc, Laboratorios Grifols, S.A. | Prescription Medication | 2023-05-11 |
| BTG International Inc., Cangene BioPharma, LLC | Other Medication | 2023-05-06 |
| Nexus Pharmaceuticals LLC | Prescription Medication | 2023-05-04 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2023-04-27 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2023-04-20 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2023-04-15 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2023-04-13 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2023-04-11 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2023-03-23 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2023-02-23 |
| La Jolla Pharmaceutical Company, Bora Pharmaceuticals Injectables Inc. | Prescription Medication | 2023-01-12 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2023-01-11 |
| Medicure International Inc., Cangene BioPharma, LLC | Prescription Medication | 2023-01-03 |
| BTG International Inc., Cangene BioPharma, LLC | Other Medication | 2022-11-30 |
| BTG International Inc., Cangene BioPharma, LLC | Other Medication | 2022-11-19 |
| La Jolla Pharmaceutical Company, Bora Pharmaceuticals Injectables Inc. | Prescription Medication | 2022-09-15 |
| Nexus Pharmaceuticals LLC | Prescription Medication | 2022-03-04 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2022-02-25 |
| Nexus Pharmaceuticals LLC | Prescription Medication | 2022-02-15 |
| Medicure International Inc, Baxter Healthcare Corporation, Cangene BioPharma, LLC, Laboratorios Grifols, S.A. | Prescription Medication | 2022-01-05 |
| BTG International Inc., Cangene BioPharma, LLC | Other Medication | 2021-11-23 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2021-11-09 |
| Praxgen Pharmaceuticals LLC, Cangene Biopharma LLC | Prescription Medication | 2021-11-03 |
| Nexus Pharmaceuticals LLC | Prescription Medication | 2021-10-06 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2021-08-12 |
| Bausch Health US LLC, Cangene bioPharma LLC | Prescription Medication | 2021-08-03 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2021-07-13 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2021-06-19 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2021-06-17 |
| Apellis Pharmaceuticals, Inc., Juzen Chemical Corporation, Bachem AG, Eurofins Lancaster Laboratories, LLC, Eurofins Advantar Laboratories, LLC, Bora Pharmaceuticals Injectables Inc., Nelson Laboratories, LLC, AndersonBrecon Inc, Cenexi HSC | Prescription Medication | 2021-06-15 |
| Sedor Pharmaceuticals, LLC, Cangene BioPharma, LLC | Prescription Medication | 2021-06-01 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2021-04-09 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2021-03-13 |
| Bausch Health US LLC, Cangene bioPharma LLC | Prescription Medication | 2021-02-03 |
| Medicure International Inc., Cangene BioPharma, LLC | Prescription Medication | 2021-01-12 |
| Medicure International Inc, Baxter Healthcare Corporation, Cangene BioPharma, LLC, Laboratorios Grifols, S.A. | Prescription Medication | 2020-12-25 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2020-12-22 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2020-11-20 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2020-09-15 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2020-09-11 |
| Nexus Pharmaceuticals LLC | Prescription Medication | 2020-08-15 |
| La Jolla Pharmaceutical Company, Bora Pharmaceuticals Injectables Inc. | Prescription Medication | 2020-06-22 |
| La Jolla Pharmaceutical Company, Bora Pharmaceuticals Injectables Inc. | Prescription Medication | 2020-06-17 |
| SunGen Pharma, LLC, Cangene Biopharma LLC | Prescription Medication | 2020-04-29 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2020-04-01 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2020-03-27 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2020-03-18 |
| Bausch Health US LLC, Cangene bioPharma LLC | Prescription Medication | 2020-01-15 |
| Bausch Health US LLC, Cangene bioPharma LLC | Prescription Medication | 2020-01-14 |
| La Jolla Pharmaceutical Company, Bora Pharmaceuticals Injectables Inc. | Prescription Medication | 2019-12-31 |
| BTG International Inc., Cangene BioPharma, LLC | Other Medication | 2019-12-12 |
| Medicure International Inc., Cangene BioPharma, LLC | Prescription Medication | 2019-12-10 |
| Bausch Health US LLC, Cangene bioPharma LLC | Prescription Medication | 2019-11-16 |
| SunGen Pharma, LLC, Cangene Biopharma LLC | Prescription Medication | 2019-11-06 |
| Bausch Health US LLC, Cangene bioPharma LLC | Prescription Medication | 2019-10-29 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2019-10-17 |
| Acrotech Biopharma Inc, Bora Pharmaceuticals Injectables Inc | Prescription Medication | 2019-10-15 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2019-09-13 |
| Nexus Pharmaceuticals LLC | Prescription Medication | 2019-08-13 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2019-06-17 |
| Medicure International Inc, Baxter Healthcare Corporation, Cangene BioPharma, LLC, Laboratorios Grifols, S.A. | Prescription Medication | 2019-05-29 |
| TOLMAR Inc., Bachem AG, Isomedix Operations Inc, Piramal Pharma Limited, TOLMAR 1201 Cornerstone LLC | Prescription Medication | 2019-04-27 |
| Mallinckrodt ARD LLC, Cangene BioPharma, LLC | Prescription Medication | 2019-04-12 |
| BTG International Inc., Cangene BioPharma, LLC | Other Medication | 2018-10-24 |
| NCAGE Code | 5N9V9 | CANGENE BIOPHARMA LLC!DBA EMERGENT BIOSOLUTIONS |
| CAGE Code | 5N9V9 | CANGENE BIOPHARMA LLC EMERGENT BIOSOLUTIONS |
| CAGE Code | 81E46 | CANGENE BIOPHARMA LLC ROCKVILLE MANUFACTURING SITE |
| S.A.M. Registration | 5N9V9 [50783398] | CANGENE BIOPHARMA LLC EMERGENT BIOSOLUTIONS |
| S.A.M. Registration | 81E46 [81005625] | CANGENE BIOPHARMA LLC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020060633723 | Stadersand,Federal Republic of Germany -> Baltimore, Maryland | 1 CASE 11175 KG 330 X 262 X 334 CM 1 CASE 4178 KG 345 X 237 X 295 CM INCL. IMO 2 / UN 10784 1 CASE 1771 KG 455 X 220 X 172 CM 1 CASE 2674 KG 580 X 210 X 172 CM 1 CASE 3338 KG 485 X 230 X 259 CM FREEZE DRYER PARTS UNITTYP E2-100 DS SNLYO 24669 SNLYOSHUTTLE 24670 5 CRATES TOTAL | 5 PCS |