Intas Pharmaceuticals Ltd.
Overview
Intas Pharmaceuticals Ltd. is a leading Indian pharmaceutical company known for its extensive range of products spanning various therapeutic areas. The company is dedicated to providing affordable healthcare solutions with a strong focus on research and development.
Therapeutic areas
API / Drug Master Files
Intas Pharmaceuticals Ltd. holds 40 active (47 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.
- PALBOCICLIBActive2026-02-20
- MYCOPHENOLATE MOFETIL USPActive2026-02-03
- OLAPARIBActive2025-09-12
- RUXOLITINIB PHOSPHATEActive2024-07-24
- BENDAMUSTINE HYDROCHLORIDEActive2023-08-31
- TOFACITINIB CITRATEActive2022-06-22
- SODIUM THIOSULFATEActive2022-02-15
- GEMCITABINE HYDROCHLORIDE USP (PROCESS-III)Active2021-12-24
- PREGABALIN USP (PROCESS-II)Active2021-11-22
- RIBOCICLIB SUCCINATEActive2021-09-30
- PACLITAXEL (SEMI SYNTHETIC) USP (PROCESS-II)Active2021-09-02
- DASATINIBActive2020-12-02
- CARFILZOMIBActive2020-09-08
- DIROXIMEL FUMARATEActive2020-03-27
- DOXORUBICIN HYDROCHLORIDE USPActive2020-01-27
Showing 15 of 47 Drug Master Files.
FDA compliance signals
34 FDA enforcement records linked to this company.
- warning_letter2026-03-30
FDA Warning Letter (drug product)
- warning_letter2023-11-21
FDA Warning Letter (drug product)
- warning_letter2023-07-28
FDA Warning Letter (drug product)
- 4832022-12-02
Absence of Written Procedures
- 4832022-12-02
Following/documenting laboratory controls
- 4832022-12-02
Complete test data included in records
- 4832022-12-02
Test methods
- 4832022-12-02
Procedures for sterile drug products
- 4832022-12-02
Results not used for expiration dates, storage cond.
- 4832022-12-02
Computer control of master formula records
- 4832022-12-02
Extent of discrepancy, failure investigations
- 4832022-12-02
Environmental Monitoring System
- 4832022-12-02
Investigations of discrepancies, failures
- 4832022-12-02
Procedures not in writing, fully followed
- 4832019-08-02
Procedures not in writing, fully followed
Related companies
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.