FDC Limited
Overview
FDC Limited is a leading pharmaceutical company based in India, specializing in the development, manufacturing, and distribution of a wide range of healthcare products, including prescription pharmaceuticals, OTC (over-the-counter) medications, and food products. The company is known for its research and development capabilities and has a sustained focus on innovative therapies.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances FDC Limited is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
FDC Limited holds 15 active (23 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- SEMAGLUTIDEActive2026-03-31
- Arformoterol TartrateActive2026-03-31
- NEPAFENACActive2024-10-04
- BIMATOPROST USPActive2024-08-12
- BRINZOLAMIDE USPActive2024-03-06
- DORZOLAMIDE HYDROCHLORIDE USP (PROCESS II)Active2019-04-02
- CINNARIZINEActive2017-09-07
- OLOPATADINE HYDROCHLORIDE USPActive2015-06-23
- LATANOPROST USPActive2010-05-18
- BRIMONIDINE TARTRATE USPActive2007-09-17
- ECONAZOLE NITRATE USPActive1993-08-09
- TIMOLOL MALEATE USPActive1992-07-27
- FLURBIPROFEN USPActive1989-09-07
- ALBUTEROL SULFATE USPActive1988-12-12
- MICONAZOLE NITRATE USPActive1988-03-04
Showing 15 of 23 Drug Master Files.
FDA compliance signals
19 FDA enforcement records linked to this company.
- recall — Class II2025-08-06
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
- recall — Class II2025-05-14
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- recall — Class II2025-03-26
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
- recall — Class II2025-02-12
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- recall — Class II2025-01-15
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
- recall — Class II2024-12-18
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- recall — Class II2024-11-13
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
- recall — Class II2024-08-28
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- recall — Class II2024-08-21
Defective container; yellow colored spike from cap lodged in the nozzle
- recall — Class II2024-08-07
Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
- recall — Class II2024-05-15
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
- 4832018-08-16
Absence of Written Procedures
- 4832018-08-16
Procedures for sterile drug products
- 4832018-08-16
Following/documenting laboratory controls
- 4832018-08-16
Acceptance criteria for sampling & testing
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