Amneal Oncology Private 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. S-3, S-4, S-5A, TSIIC-SEZ Village-Polepally Mandal-Jadcherla MAHABOOBNAGAR, Mahaboobnagar, TG 509301, India (IND)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3005903939 · DUNS 860037948
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2019-10-25
- VAIDrug Quality Assurance2018-03-15
Drugs this plant is listed as making
4 distinct drugs across 5 products name this site in their FDA label.
- BortezomibShilpa Medicare Limited
- NelarabineAmneal Pharmaceuticals LLC
- plerixaforAmneal Pharmaceuticals LLC
- RomidepsinAmneal Pharmaceuticals LLC
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.