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. M-2 and M-2-A, Special Economic Zone, Phase II, MISC Zone Apparel Park, Pithampur, Dhar, Madhya Pradesh 454775, India (IND)
- Operations here
- api manufacturemanufacturepack
- FDA identifiers
- FEI 3009831799 · DUNS 650582310
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-09-27
- VAIDrug Quality Assurance2020-02-11
- NAIDrug Quality Assurance2017-07-28
- NAIDrug Quality Assurance2015-08-05
Drugs this plant is listed as making
25 distinct drugs across 47 products name this site in their FDA label.
- BosentanLupin Pharmaceuticals, Inc.
- desogestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.
- Drospirenone And Ethinyl EstradiolLupin Pharmaceuticals, Inc.
- drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calciumLupin Pharmaceuticals, Inc.
- Hydrocortisone ValerateLupin Pharmaceuticals, Inc.
- LeflunomideLupin Pharmaceuticals, Inc.
- Levonorgestrel and Ethinyl EstradiolLupin Pharmaceuticals, Inc.
- levonorgestrel and ethinyl estradiol and ferrous bisglycinateLupin Pharmaceuticals, Inc.
- Levothyroxine SodiumLupin Pharmaceuticals, Inc.
- NorethindroneLupin Pharmaceuticals, Inc.
- Norethindrone Acetate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.
- Norethindrone Acetate, Ethinyl Estradiol And Ferrous FumarateLupin Pharmaceuticals, Inc.
- norethindrone and ethinyl estradiolLupin Pharmaceuticals, Inc.
- Norgestimate and Ethinyl EstradiolLupin Pharmaceuticals, Inc.
- norgestrel and ethinyl estradiolLupin Pharmaceuticals, Inc.
- VareniclineLupin Pharmaceuticals, Inc.
- Varenicline TartrateLupin 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.