OrBion Pharmaceuticals 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.B5 (Part) and B6 (Part), SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram, TAMIL NADU 602117, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3004540907 · DUNS 854403569
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-10-27
- VAIDrug Quality Assurance2023-09-08
- VAIDrug Quality Assurance2019-05-31
- VAIDrug Quality Assurance2015-06-03
- NAIDrug Quality Assurance2013-06-14
- VAIDrug Quality Assurance2011-04-07
Drugs this plant is listed as making
32 distinct drugs across 59 products name this site in their FDA label.
- Acamprosate CalciumBionpharma Inc.,
- AzithromycinBionpharma Inc.
- BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDEBionpharma Inc.
- Cetirizine HydrochlorideBionpharma Inc.
- Cevimeline HydrochlorideBionpharma Inc
- cimetidineBionpharma Inc.
- colesevelam hydrochlorideBionpharma Inc.
- Dicyclomine HydrochlorideBionpharma Inc.
- divalproex sodiumBionpharma Inc.
- Enalapril maleateBionpharma Inc.
- EszopicloneBionpharma Inc.
- Fluvoxamine MaleateBionpharma Inc.
- glycopyrrolateBionpharma Inc.
- Granisetron HydrochlorideBionpharma Inc.
- Hydroxyzine Hydrochloride OralBionpharma Inc.
- Ibandronate SodiumBionpharma Inc.
- ivabradineBionpharma Inc.
- Ketorolac Tromethaminein shortageBionpharma Inc.
- LevetiracetamBionpharma Inc.
- Metformin HydrochlorideBionpharma Inc.,
- methimazoleBionpharma Inc.
- ModafinilBionpharma Inc.
- Nicardipine HydrochlorideBionpharma Inc.
- Prochlorperazine MaleateBionpharma Inc.
- RufinamideBionpharma Inc.
- Sevelamer CarbonateBionpharma Inc.
- SumatriptanBionpharma Inc.
- TerazosinBionpharma Inc.
- terbinafine hydrochlorideBionpharma Inc.
- TetrabenazineBionpharma Inc.
- ZaleplonBionpharma 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.