Optimus Pharma 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. 73/B & 73/B/2, EPIP, Pashamylaram (V), Patancheru (M), Sangareddy, Telangana, 502307 India, Hyderabad, TELANGANA 502307, India (IND)
- Operations here
- analysislabelmanufacture
- FDA identifiers
- FEI 3013914542 · DUNS 675474672
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-06-23
- NAIDrug Quality Assurance2019-09-06
Drugs this plant is listed as making
6 distinct drugs across 10 products name this site in their FDA label.
- CabergolineSomerset Therapeutics, LLC
- Ketorolac Tromethaminein shortageBionpharma Inc.
- PenicillamineBreckenridge Pharmaceutical, Inc.
- Prochlorperazine MaleateBionpharma Inc.
- tioproninCycle Pharmaceuticals Ltd.
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.