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.
Therapeutic areas
API / Drug Master Files
Lupin Limited holds 91 active (173 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.
- 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
- METHYLPREDNISOLONE SODIUM SUCCINATEActive2016-04-15
Showing 15 of 173 Drug Master Files.
FDA compliance signals
32 FDA enforcement records linked to this company.
- 4832025-09-16
Environmental Monitoring System
- 4832025-09-16
Investigations of discrepancies, failures
- 4832025-09-16
Valid stability test methods
- 4832025-09-16
Computer control of master formula records
- 4832025-09-16
Validation lacking for sterile drug products
- 4832025-09-16
Procedures for sterile drug products
- 4832025-07-17
Testing Each Component for Conformity with Specs
- 4832025-07-17
Investigations of discrepancies, failures
- 4832025-07-17
Written in-process control procedures
- 4832023-07-11
Sample identification and other information
- 4832023-07-11
Complete Test Data
- warning_letter2022-09-27
FDA Warning Letter (drug product)
- warning_letter2019-09-10
FDA Warning Letter (drug product)
- 4832019-01-25
Investigations of discrepancies, failures
- 4832019-01-25
Written record of complaint to include findings, follow-up
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