SMS 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
- Unit-II, Plot No.24&24B and 36&37, S.V.Co-Operative Industrial Estate, Bachupally, Medchal-Malkajgiri District, Hyderabad, Telangana 500090, India (IND)
- Operations here
- analysisapi manufacturelabelpack
- FDA identifiers
- FEI 3003971663 · DUNS 650460954
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-03-21
- NAIDrug Quality Assurance2017-11-17
- VAIDrug Quality Assurance2014-04-18
- NAIDrug Quality Assurance2011-02-04
Drugs this plant is listed as making
5 distinct drugs across 8 products name this site in their FDA label.
- macitentan and tadalafilActelion Pharmaceuticals US, Inc.
- meloxicam, rizatriptanAxsome Therapeutics, Inc.
- SumatriptanSun Pharmaceutical Industries, Inc.
- TadalafilCipla USA 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.