Neuland Laboratories Limited

Overview

Neuland Laboratories Limited is a leading Indian pharmaceutical company engaged in the manufacturing and sale of active pharmaceutical ingredients (APIs). It specializes in serving the pharmaceutical industry with a focus on complex and niche products. The company is well-regarded for its emphasis on research and development and its state-of-the-art manufacturing capabilities.

Therapeutic areas

API / Drug Master Files

Neuland Laboratories Limited holds 75 active (86 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.

• EDOXABAN TOSYLATE MONOHYDRATEActive2026-03-30
• ENALAPRIL MALEATE USP (PROCESS-II)Active2026-02-12
• VONOPRAZAN FUMARATEActive2025-09-26
• DABIGATRAN ETEXILATE MESYLATEActive2025-03-28
• DIFELIKEFALIN ACETATEActive2025-03-26
• EMPAGLIFLOZINActive2025-01-30
• BRINZOLAMIDE (PROCESS-II, STERILE)Active2024-06-04
• DAPAGLIFLOZIN PROPANEDIOL USP (MONOHYDRATE)Active2024-04-29
• APIXABAN (PROCESS-II)Active2024-01-31
• BRINZOLAMIDE USP (PROCESS-II)Active2023-11-09
• MIRABEGRONActive2023-08-31
• VOXELOTOR ADIPIC ACID CO-CRYSTALActive2023-04-04
• VOXELOTORActive2023-03-31
• TAFAMIDIS (FORM-4)Active2023-03-31
• LINEZOLID USP (PROCESS-II)Active2022-03-31

Showing 15 of 86 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Neuland Laboratories Limited in our records. PharmaTek screens the full directory against live FDA enforcement data.