Shilpa Medicare 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
- S-20 to S-26, Pharmaceutical Formulations SEZ; TSIIC, Green Industrial Park, Polepally, Jadcherla, Mahabubnagar, Telangana 509301, India (IND)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3009876430 · DUNS 650644136
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2020-02-25
- VAIDrug Quality Assurance2019-09-06
- VAIDrug Quality Assurance2017-11-30
- NAIDrug Quality Assurance2017-07-28
- NAIDrug Quality Assurance2016-07-26
- VAIDrug Quality Assurance2015-08-26
Drugs this plant is listed as making
3 distinct drugs across 4 products name this site in their FDA label.
- Azacitidinein shortageDr. Reddy's Laboratories Inc.
- imatinib mesylateAscend Laboratories, 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.