USV PRIVATE LTD
Overview
USV PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 31 active FDA Type II Drug Master Files, covering ACITRETIN USP; BLENDED METFORMIN HCL; DAPAGLIFLOZIN (DAPAGLIFLOZIN 30% W/W SOLUTION IN ISOPROPYL ALCOHOL); DOLASETRON MESYLATE USP; DONEPEZIL HYDROCHLORIDE USP MONOHYDRATE; ELAGOLIX SODIUM.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances USV PRIVATE 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
USV PRIVATE LTD holds 31 active (41 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.
- ELAGOLIX SODIUMActive2024-09-30
- EMPAGLIFLOZINActive2023-12-30
- RIVAROXABAN USP (MICRONISED)Active2023-03-31
- DAPAGLIFLOZIN (DAPAGLIFLOZIN 30% W/W SOLUTION IN ISOPROPYL ALCOHOL)Active2022-09-30
- TICAGRELORActive2021-09-24
- ETELCALCETIDE HYDROCHLORIDEActive2021-07-22
- TRIMETAZIDINE DIHYDROCHLORIDEActive2021-03-30
- SUGAMMADEX SODIUMActive2019-08-31
- ICATIBANT ACETATEActive2018-12-07
- DOLASETRON MESYLATE USPActive2018-09-28
- PALONOSETRON HYDROCHLORIDEActive2015-09-29
- REGADENOSONActive2015-06-23
- NATEGLINIDE USP [MICRONISED]Active2013-03-25
- OLOPATADINE HYDROCHLORIDE USPActive2011-01-31
- ZOLEDRONIC ACID (MONOHYDRATE)Active2010-12-24
Showing 15 of 41 Drug Master Files.
FDA compliance signals
28 FDA enforcement records linked to this company.
- recall — Class II2025-10-29
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
- 4832025-09-12
Cleaning / Sanitizing / Maintenance
- 4832022-11-17
Written program not followed
- 4832022-11-17
Absence of Written Procedures
- 4832022-11-17
Lab controls established, including changes
- 4832022-11-17
Procedures for sterile drug products
- 4832022-11-17
Training , Education , Experience overall
- 4832022-11-17
In-process materials specifications testing
- 4832022-11-17
Investigations of discrepancies, failures
- 4832022-11-17
Procedure Deviations Recorded and Justified
- 4832022-11-17
Acceptance of drug products
- 4832022-11-17
Validation lacking for sterile drug products
- 4832022-08-19
Failure to develop written procedures
- 4832017-08-02
Establish reliability of supplier's C of A
- 4832017-08-02
Procedures for sterile drug products
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