Laurus Labs Limited

Overview

Laurus Labs Limited is an Indian pharmaceutical company that specializes in the development and manufacturing of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and custom synthesis services for various therapeutic areas. The company is known for its strong focus on quality and innovation in the global pharmaceutical market.

Therapeutic areas

API / Drug Master Files

Laurus Labs Limited holds 59 active (61 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.

• DAPAGLIFLOZINActive2025-09-29
• HYDROCHLOROTHIAZIDE USPActive2025-08-22
• TENOFOVIR ALAFENAMIDE MONOFUMARATEActive2025-03-28
• DOLUTEGRAVIR SODIUM (HXA)Active2024-08-21
• DARUNAVIR ETHANOLATEActive2024-05-15
• VALSARTAN USPActive2023-08-18
• 5-FLUOROCYTOSINE (FLUCYTOSINE) USPActive2022-11-30
• PAZOPANIB HYDROCHLORIDEActive2022-02-28
• BICTEGRAVIR SODIUMActive2021-12-24
• TENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-2)Active2021-12-22
• SODIUM ZIRCONIUM CYCLOSILICATEActive2021-12-10
• APALUTAMIDEActive2021-09-14
• SITAGLIPTIN PHOSPHATE MONOHYDRATE USPActive2021-03-16
• OSELTAMIVIR PHOSPHATE USPActive2020-01-10
• ERLOTINIB HYDROCHLORIDEActive2020-01-08

Showing 15 of 61 Drug Master Files.

FDA compliance signals

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