SYNTHOKEM LABS PRIVATE LTD

Overview

SYNTHOKEM LABS PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 25 active FDA Type II Drug Master Files, covering ACAMPROSATE CALCIUM USP; ANASTROZOLE USP; ATORVASTATIN CALCIUM USP; BEMPEDOIC ACID; CINACALCET HYDROCHLORIDE; CLARITHROMYCIN.

API / Drug Master Files

SYNTHOKEM LABS PRIVATE LTD holds 25 active (25 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.

• BEMPEDOIC ACIDActive2025-11-12
• IBRUTINIBActive2025-07-01
• PAZOPANIB HYDROCHLORIDEActive2025-05-19
• MIRABEGRONActive2025-04-22
• ELTROMBOPAG OLAMINEActive2025-04-22
• EZETIMIBE USPActive2025-01-04
• PRAZOSIN HYDROCHLORIDEActive2024-01-03
• LAMIVUDINE COUPLED ESTER (NON-STERILE DRUG INTERMEDIATE)Active2021-02-25
• QUETIAPINE FUMARATE USPActive2019-02-06
• SCHIFF BASE (NON STERILE DRUG SUBSTANCE INTERMEDIATE)Active2017-12-06
• ANASTROZOLE USPActive2011-10-03
• FEXOFENADINE HYDROCHLORIDE USPActive2011-03-05
• TEMOZOLOMIDE USPActive2010-12-17
• CINACALCET HYDROCHLORIDEActive2010-10-29
• ATORVASTATIN CALCIUM USPActive2008-12-10

Showing 15 of 25 Drug Master Files.

FDA compliance signals

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