Onesource Specialty Pharma 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
- Sterile Product Division, Opp IIM, Bilekahalli, Bannerghatta Road,, Bengaluru, Karnataka 560076, India (IND)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3003813519 · DUNS 676199117
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-03-28
- VAIDrug Quality Assurance2019-12-20
- VAIDrug Quality Assurance2018-03-13
- VAIDrug Quality Assurance2016-03-16
- OAIDrug Quality Assurance2014-08-08
- VAIDrug Quality Assurance2013-08-12
- VAIDrug Quality Assurance2011-09-29
- NAIDrug Quality Assurance2009-03-17
Drugs this plant is listed as making
8 distinct drugs across 25 products name this site in their FDA label.
- Bupivacaine Hydrochloridein shortageOnesource Specialty Pharma Limited
- Fosaprepitant DimeglumineSteriscience Specialties Private Limited
- Ketorolac Tromethaminein shortageOnesource Specialty Pharma Limited
- midazolam hydrochloridein shortageSomerset Therapeutics, Llc
- ondansetron hydrochlorideOnesource Specialty Pharma Limited
- sumatriptanOnesource Specialty Pharma Limited
- Thiamine HydrochlorideOnesource Specialty Pharma Limited
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.