Natco Pharma
Overview
Natco Pharma is a leading pharmaceutical company based in India, specializing in the development and manufacturing of pharmaceutical products. The company is renowned for its focus on research and development in the area of generic and specialty medicines.
Therapeutic areas
API / Drug Master Files
Natco Pharma holds 51 active (62 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.
- NUSINERSEN SODIUMActive2026-03-25
- RUXOLITINIB PHOSPHATEActive2026-01-13
- VENETOCLAXActive2024-11-15
- RISDIPLAMActive2024-04-30
- LURBINECTEDINActive2024-03-25
- CAPMATINIB HYDROCHLORIDEActive2024-03-21
- CIDOFOVIR DIHYDRATE USPActive2023-08-23
- NILOTINIB HYDROCHLORIDE MONOHYDRATEActive2022-12-02
- ALECTINIB HYDROCHLORIDEActive2022-03-25
- CABOZANTINIB (S)-MALATEActive2022-02-28
- ERIBULIN MESYLATEActive2022-01-06
- IDELALISIBActive2021-11-18
- ACALABRUTINIB DIHYDRATEActive2021-09-15
- CARMUSTINEActive2020-03-03
- TRIFLURIDINEActive2019-08-08
Showing 15 of 62 Drug Master Files.
FDA compliance signals
16 FDA enforcement records linked to this company.
- 4832025-06-19
Investigations of discrepancies, failures
- 4832025-06-19
Environmental Monitoring System
- 4832025-06-19
Buildings of Suitable Size, Construction, Location
- 4832025-06-19
Procedures for sterile drug products
- 4832025-06-19
Validation lacking for sterile drug products
- 4832025-06-19
Cleaning / Sanitizing / Maintenance
- 4832025-06-19
Procedures not in writing, fully followed
- recall — Class II2024-04-17
CGMP Deviations
- warning_letter2024-04-08
FDA Warning Letter (drug product)
- recall — Class II2024-02-14
CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.
- 4832017-01-24
Written program not followed
- 4832017-01-24
Procedures for sterile drug products
- 4832017-01-24
Mix-up
- 4832017-01-24
Released Drug Products Area
- 4832017-01-24
Scientifically sound laboratory controls
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