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
- Central Laboratory Analytical Services Building No 2, First Floor Survey No 186 189 190, Gagillapur (V), Medchal-Malkajgiri, Hyderabad, India 500043, India (IND)
- Operations here
- analysis
- FDA identifiers
- FEI 3014615000 · DUNS 677605501
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-06-25
- NAIDrug Quality Assurance2020-03-05
Drugs this plant is listed as making
1 distinct drugs across 2 products name this site in their FDA label.
- macitentan and tadalafilActelion Pharmaceuticals US, 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.