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, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep, Madhya Pradesh 462046, India (IND)
- Operations here
- api manufacturemanufacturepack
- FDA identifiers
- FEI 3002807511 · DUNS 725504448
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2022-11-23
- OAIDrug Quality Assurance2018-12-04
- VAIDrug Quality Assurance2016-02-19
- VAIDrug Quality Assurance2011-09-23
- VAIDrug Quality Assurance2009-11-30
- OAIDrug Quality Assurance2008-11-12
Drugs this plant is listed as making
6 distinct drugs across 17 products name this site in their FDA label.
- CefadroxilLupin Pharmaceuticals, Inc.
- CefdinirLupin Pharmaceuticals, Inc.
- CefiximeLupin Pharmaceuticals, Inc.
- CefprozilLupin Pharmaceuticals, Inc.
- CephalexinLupin 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.