Glenmark 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. B-25, MIDC, Shendra, Chhatrapati Sambhajinagar (previously known as Aurangabad), Maharashtra 431154, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3009915929 · DUNS 650565703
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2024-09-20
- NAIBioresearch Monitoring2023-12-15
- NAIDrug Quality Assurance2020-02-21
- VAIDrug Quality Assurance2018-08-17
- VAIDrug Quality Assurance2016-06-17
Drugs this plant is listed as making
5 distinct drugs across 9 products name this site in their FDA label.
- abiraterone acetateNorthstar Rx Llc
- Clindamycin Phosphatein shortageGlenmark Pharmaceuticals Inc., Usa
- clobetasol propionateGlenmark Pharmaceuticals Inc., USA
- fluticasone propionateGlenmark Pharmaceuticals Inc., USA
- olopatadine hydrochloride and mometasone furoateHikma Specialty 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.