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
- Beta Lactam Division, 152/6 & 154/16, Doresanipalya, Bilekahalli, Bannerghatta Road,, Bengaluru, Karnataka 560076, India (IND)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3005652193 · DUNS 650391548
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2019-02-14
- OAIDrug Quality Assurance2015-09-01
- VAIDrug Quality Assurance2011-02-03
Drugs this plant is listed as making
8 distinct drugs across 31 products name this site in their FDA label.
- AmpicillinArmas Pharmaceuticals Inc.
- Ampicillin SodiumArmas Pharmaceuticals Inc.
- ampicillin sodium and sulbactam sodiumCivica, Inc.
- ampicillin sodium, sulbactam sodiumArmas Pharmaceuticals Inc.
- Nafcillin SodiumArmas Pharmaceuticals Inc.
- oxacillinOnesource Specialty Pharma Limited
- piperacillin and tazobactamOnesource 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.