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.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Intas Pharmaceuticals Ltd. 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
Intas Pharmaceuticals Ltd. holds 41 active (48 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.
- 5-FLUOROURACIL USPActive2026-04-09
- 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
Showing 15 of 48 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
Extent of discrepancy, failure investigations
- 4832022-12-02
Environmental Monitoring System
- 4832022-12-02
Results not used for expiration dates, storage cond.
- 4832022-12-02
Procedures for sterile drug products
- 4832022-12-02
Computer control of master formula records
- 4832022-12-02
Investigations of discrepancies, failures
- 4832022-12-02
Test methods
- 4832022-12-02
Following/documenting laboratory controls
- 4832022-12-02
Procedures not in writing, fully followed
- 4832022-12-02
Complete test data included in records
- 4832019-08-02
Suitability of testing methods verified
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