Lupin Limited
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- India
- Registered address
- A 28-1, MIDC Industrial Area, Chikalthana, Chhatrapati Sambhajinagar, Maharashtra 431210, India (IND)
- Operations here
- manufacturepack
- FDA identifiers
- FEI 3004995645 · DUNS 862272739
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-03-15
- NAIDrug Quality Assurance2020-02-14
- VAIDrug Quality Assurance2015-04-03
- NAIDrug Quality Assurance2012-07-27
- NAIDrug Quality Assurance2009-11-05
Drugs this plant is listed as making
8 distinct drugs across 15 products name this site in their FDA label.
- Amlodipine BesylateLupin Pharmaceuticals, Inc.
- MeloxicamLupin Pharmaceuticals, Inc.
- Oseltamivir PhosphateLupin Pharmaceuticals, Inc.
- rifampinin shortageLupin Pharmaceuticals, Inc.
- RivaroxabanLupin Pharmaceuticals, Inc.
- rivaroxaban granuleLupin Pharmaceuticals, Inc.
- Sertraline HydrochlorideLupin Pharmaceuticals, Inc.
- SilodosinLupin Pharmaceuticals, Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.