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-2, Plot No. M-2 and M-2-A, Special Economic Zone Phase II, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, Madhya Pradesh 454775, India (IND)
- Operations here
- manufacturepack
- FDA identifiers
- FEI 3007549629 · DUNS 863645527
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 21 drugs. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2025-07-17
- OAIDrug Quality Assurance2019-01-25
- OAIDrug Quality Assurance2017-05-19
- OAIDrug Quality Assurance2015-01-23
- NAIDrug Quality Assurance2012-06-22
- VAIDrug Quality Assurance2009-11-18
Drugs this plant is listed as making
21 distinct drugs across 98 products name this site in their FDA label.
- Amlodipine Besylate and Benazepril HydrochlorideLupin Pharmaceuticals, Inc.
- BromfenacLupin Pharmaceuticals, Inc.
- bromfenac sodiumLupin Pharmaceuticals, Inc.
- FenofibrateLupin Pharmaceuticals, Inc.
- Imipramine PamoateLupin Pharmaceuticals, Inc.
- LevetiracetamLupin Pharmaceuticals, Inc.
- LisinoprilLupin Pharmaceuticals, Inc.
- Lisinopril and HydrochlorothiazideLupin Pharmaceuticals, Inc.
- Losartan PotassiumLupin Pharmaceuticals, Inc.
- loteprednol etabonateLupin Pharmaceuticals, Inc.
- memantine hydrochlorideLupin Pharmaceuticals, Inc.
- MoxifloxacinLupin Pharmaceuticals, Inc.
- ParoxetineLupin Pharmaceuticals, Inc.
- prednisolone acetateLupin Pharmaceuticals, Inc.
- quetiapineBluePoint Laboratories
- quetiapine fumarateLupin Pharmaceuticals, Inc.
- Sertraline HydrochlorideLupin Pharmaceuticals, Inc.
- SimvastatinLupin Pharmaceuticals, Inc.
- TopiramateLupin Pharmaceuticals, Inc.
- Tramadol HydrochlorideLupin 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.