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
- Unit-3, Plot No. M-1 and M-3-A, Special Economic Zone, Phase - II, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, Madhya Pradesh 454775, India (IND)
- Operations here
- manufacturepack
- FDA identifiers
- FEI 3009107538 · DUNS 650595213
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-07-17
- VAIDrug Quality Assurance2018-10-18
- NAIDrug Quality Assurance2015-03-27
Drugs this plant is listed as making
10 distinct drugs across 16 products name this site in their FDA label.
- Betamethasone dipropionateLupin Pharmaceuticals, Inc.
- clobetasol propionateLupin Pharmaceuticals,Inc.
- DesoximetasoneLupin Pharmaceuticals, Inc.
- Diclofenac SodiumLupin Pharmaceuticals, Inc.
- FluocinonideLupin Pharmaceuticals,Inc.
- Hydrocortisone ButyrateLupin Pharmaceuticals, Inc.
- Nystatin and Triamcinolone AcetonideLupin Pharmaceuticals, Inc.
- TestosteroneLupin 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.