SAPTAGIR LABORATORIES PRIVATE LTD

Overview

SAPTAGIR LABORATORIES PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 9 active FDA Type II Drug Master Files, covering (S)-1-PHENYL-1,2,3,4-TETRAHYDROISOQUINOLINE [INTERMEDIATE OF SOLIFENACIN SUCCINATE; ARIPIPRAZOLE USP; EDOXABAN TOSYLATE MONOHYDRATE; EZETIMIBE SILYLATED DIOL INTERMEDIATE (INTERMEDIATE OF EZETIMIBE); EZETIMIBE USP; FENOFIBRATE USP.

API / Drug Master Files

SAPTAGIR LABORATORIES PRIVATE LTD holds 9 active (9 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.

• ARIPIPRAZOLE USPActive2025-03-31
• FENOFIBRATE USPActive2024-12-28
• EDOXABAN TOSYLATE MONOHYDRATEActive2024-12-13
• TAFAMIDIS MEGLUMINEActive2024-03-25
• TAFAMIDISActive2024-03-11
• EZETIMIBE SILYLATED DIOL INTERMEDIATE (INTERMEDIATE OF EZETIMIBE)Active2023-02-08
• TERBINAFINE HYDROCHLORIDE USPActive2022-11-07
• EZETIMIBE USPActive2022-09-23
• (S)-1-PHENYL-1,2,3,4-TETRAHYDROISOQUINOLINE [INTERMEDIATE OF SOLIFENACIN SUCCINATEActive2022-08-05

FDA compliance signals

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