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-1, Plot No. 6A1, 6A2, Sector - 17, Special Economic Zone, Mihan, Nagpur, Maharashtra 441108, India (IND)
- Operations here
- manufacturepack
- FDA identifiers
- FEI 3009843207 · DUNS 650759348
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-07-11
- NAIDrug Quality Assurance2019-08-08
- NAIDrug Quality Assurance2018-05-11
- NAIDrug Quality Assurance2015-03-27
Drugs this plant is listed as making
27 distinct drugs across 85 products name this site in their FDA label.
- Azilsartan medoxomilLupin Pharmaceuticals, Inc.
- celecoxibLupin Pharmaceuticals, Inc.
- ClobazamLupin Pharmaceuticals, Inc.
- Clomipramine Hydrochloride CapsulesLupin Pharmaceuticals, Inc.
- Clonidine HydrochlorideLupin Pharmaceuticals, Inc.
- DapagliflozinLupin Pharmaceuticals, Inc.
- Dapagliflozin And Metformin HydrochlorideLupin Pharmaceuticals, Inc.
- DarunavirLupin Pharmaceuticals, Inc.
- Divalproex sodiumLupin Pharmaceuticals, Inc.
- doxyclycline hyclateLupin Pharmaceuticals, Inc.
- DoxycyclineLupin Pharmaceuticals, Inc.
- Ethacrynic AcidLupin Pharmaceuticals, Inc.
- Ethambutol HydrochlorideLupin Pharmaceuticals, Inc.
- FenofibrateLupin Pharmaceuticals, Inc.
- Fluoxetine HydrochlorideLupin Pharmaceuticals, Inc.
- LevetiracetamLupin Pharmaceuticals, Inc.
- LisinoprilQuallent Pharmaceuticals Health LLC
- Lisinopril and HydrochlorothiazideLupin Pharmaceuticals, Inc.
- lurasidone hydrochlorideLupin Pharmaceuticals, Inc.
- memantine hydrochlorideLupin Pharmaceuticals, Inc.
- Metformin HydrochlorideLupin Pharmaceuticals, Inc.
- mirabegronLupin Pharmaceuticals, Inc.
- PenicillamineLupin Pharmaceuticals, Inc.
- Sevelamer hydrochlorideLupin Pharmaceuticals, Inc.
- TolvaptanLupin 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.