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.
Therapeutic areas
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.
- Arformoterol TartrateActive2026-03-31
- SEMAGLUTIDEActive2026-03-31
- 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
Complaint Investigation/Follow-Up Findings
- 4832018-08-16
Acceptance criteria for sampling & testing
- 4832018-08-16
Following/documenting laboratory controls
- 4832018-08-16
Procedures not in writing, fully followed
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