Macleods Pharmaceuticals 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
- Plot No M-50 to M-54-A Indore, Special Economic Zone,Phase II, Pithampur., Dhar, Madhya Pradesh 454774, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3018011011 · DUNS 854247775
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-08-23
Drugs this plant is listed as making
5 distinct drugs across 17 products name this site in their FDA label.
- amlodipine and valsartanMacleods Pharmaceuticals Limited
- CandesartanMacleods Pharmaceuticals Limited
- IrbesartanNorthStar RxLLC
- Labetalol HydrochlorideMacleods Pharmaceuticals Limited
- tenofovir disoproxil fumarateMacleods Pharmaceuticals Limited
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.