Lupin Limited
Overview
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, specializing in the manufacture and sale of branded and generic formulations, active pharmaceutical ingredients (APIs), and biotechnology products. Established in 1968 by Dr. Desh Bandhu Gupta, the company has expanded its presence across over 100 countries, focusing on therapeutic areas such as cardiovascular, anti-tuberculosis, and diabetology.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Lupin Limited is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
Lupin Limited holds 92 active (174 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.
- CHOLIC ACIDActive2026-04-10
- CEPHALEXIN USP (ENZYMATIC)Active2025-03-13
- ALBUTEROL SULFATEActive2024-04-12
- UMECLIDINIUM BROMIDEActive2023-04-11
- FLUTICASONE FUROATEActive2022-11-21
- VILANTEROL TRIFENATATEActive2022-03-18
- CEFUROXIME ACIDActive2021-04-12
- BICTEGRAVIR SODIUM (MICRONIZED)Active2021-04-09
- TOLVAPTANActive2019-05-03
- TENOFOVIR ALAFENAMIDE FUMARATE (PROCESS-B)Active2019-03-19
- BREXPIPRAZOLEActive2019-02-07
- RIFAXIMIN (PROCESS B)Active2017-10-17
- VARENICLINE TARTRATEActive2017-04-13
- VORTIOXETINE HYDROBROMIDEActive2017-03-23
- HYDROCORTISONE VALERATE USPActive2016-12-30
Showing 15 of 174 Drug Master Files.
FDA compliance signals
32 FDA enforcement records linked to this company.
- 4832025-09-16
Environmental Monitoring System
- 4832025-09-16
Validation lacking for sterile drug products
- 4832025-09-16
Procedures for sterile drug products
- 4832025-09-16
Valid stability test methods
- 4832025-09-16
Investigations of discrepancies, failures
- 4832025-09-16
Computer control of master formula records
- 4832025-07-17
Written in-process control procedures
- 4832025-07-17
Testing Each Component for Conformity with Specs
- 4832025-07-17
Investigations of discrepancies, failures
- 4832023-07-11
Complete Test Data
- 4832023-07-11
Sample identification and other information
- warning_letter2022-09-27
FDA Warning Letter (drug product)
- warning_letter2019-09-10
FDA Warning Letter (drug product)
- 4832019-01-25
Computer control of master formula records
- 4832019-01-25
Training , Education , Experience overall
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