J.B. Chemicals & Pharmaceuticals Ltd.

Overview

J.B. Chemicals & Pharmaceuticals Ltd. is a prominent pharmaceutical company based in India, engaged in the manufacture and marketing of a range of specialized products. It is known for its strong focus on research and development, with a diverse portfolio that spans numerous therapeutic areas.

Therapeutic areas

API / Drug Master Files

J.B. Chemicals & Pharmaceuticals Ltd. holds 41 active (45 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.

• LITHIUM CARBONATE USPActive2025-01-31
• SITAGLIPTIN PHOSPHATE USPActive2024-01-31
• ESZOPICLONEActive2023-12-15
• MESALAMINE USPActive2023-10-14
• VALSARTAN USPActive2023-08-23
• QUETIAPINE FUMARATE USPActive2023-03-22
• ALLOPURINOL USPActive2023-01-20
• AZITHROMYCIN DIHYDRATEActive2022-11-22
• LOSARTAN POTASSIUM USPActive2022-09-23
• ACETAMINOPHEN USP (PARACETAMOL USP)Active2022-07-28
• CLOPIDOGREL BISULFATE USPActive2022-06-16
• FENOFIBRATE USPActive2022-01-05
• PANTOPRAZOLE SODIUM USPActive2021-12-28
• LAMOTRIGINE USPActive2021-12-20
• LEVETIRACETAM USPActive2021-11-27

Showing 15 of 45 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to J.B. Chemicals & Pharmaceuticals Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.