SHILPA PHARMA LIFESCIENCES LTD

Overview

SHILPA PHARMA LIFESCIENCES LTD is an active pharmaceutical ingredient (API) supplier with 55 active FDA Type II Drug Master Files, covering ABIRATERONE ACETATE USP; ANASTROZOLE USP; AXITINIB; AZACITIDINE; BENDAMUSTINE HCL; BICALUTAMIDE USP.

API / Drug Master Files

SHILPA PHARMA LIFESCIENCES LTD holds 55 active (55 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.

• OCTREOTIDE ACETATE USPActive2026-01-29
• URSODIOL USP (BOVINE ORIGIN)Active2026-01-28
• DESMOPRESSIN ACETATE USPActive2026-01-22
• LIRAGLUTIDEActive2026-01-20
• PALBOCICLIBActive2025-10-16
• METHOTREXATE SODIUMActive2025-10-14
• URSODIOL USPActive2025-07-08
• METHOTREXATE USPActive2025-06-24
• ABIRATERONE ACETATE USPActive2025-06-10
• DASATINIBActive2025-05-16
• ELTROMBOPAG OLAMINEActive2024-05-10
• BORTEZOMIBActive2022-03-09
• NILOTINIBActive2021-09-21
• NIFEDIPINE-USPActive2021-09-11
• PHENYLEPHRINE HYDROCHLORIDE, USPActive2021-09-11

Showing 15 of 55 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to SHILPA PHARMA LIFESCIENCES LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.