Somerset Therapeutics 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
- 54/1, Boodihal Village Nelamangala Taluk, Bengaluru, Karnataka 562123, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003821988 · DUNS 677236695
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 48 drugs, 5 already in shortage. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2025-02-21
- VAIDrug Quality Assurance2023-10-27
- OAIDrug Quality Assurance2022-04-04
- OAIDrug Quality Assurance2020-02-19
- VAIDrug Quality Assurance2019-07-23
- VAIDrug Quality Assurance2017-12-05
- NAIDrug Quality Assurance2017-04-24
- VAIDrug Quality Assurance2013-08-20
- OAIDrug Quality Assurance2011-09-20
- VAIDrug Quality Assurance2009-03-31
Drugs this plant is listed as making
48 distinct drugs across 113 products name this site in their FDA label.
- AcetylcysteineSomerset Therapeutics, LLC
- Atropine sulfatein shortageSomerset Therapeutics, LLC
- Atropine Sulfate Monohydratein shortageSomerset Therapeutics, LLC
- Azelastine HydrochlorideSomerset Therapeutics, LLC
- Bepotastine BesilateSomerset Therapeutics, LLC
- BimatoprostSomerset Therapeutics, LLC
- Brimonidine TartrateSomerset Therapeutics, LLC
- Brimonidine Tartrate and Timolol MaleateSomerset Therapeutics, LLC
- Buprenorphine HydrochlorideSomerset Therapeutics, LLC
- Calcium Chloride DihydrateSomerset Therapeutics, LLC
- Cisatracurium BesylateSomerset Therapeutics, LLC
- CyanocobalaminSomerset Therapeutics, LLC
- Dexamethasone Sodium Phosphatein shortageSomerset Therapeutics, LLC
- Dexmedetomidine Hydrochloridein shortageSomerset Therapeutics, LLC
- Dicyclomine HydrochlorideSomerset Therapeutics, LLC
- Dorzolamide HydrochlorideSomerset Therapeutics, LLC
- DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATESomerset Therapeutics, LLC
- Epinastine HydrochlorideSomerset Therapeutics, LLC
- GlycopyrrolateSomerset Therapeutics, LLC
- Haloperidol DecanoateSomerset Therapeutics, LLC
- LacosamideSomerset Therapeutics, LLC
- LatanoprostSomerset Therapeutics, LLC
- MethocarbamolSomerset Therapeutics, LLC
- Moxifloxacin HydrochlorideSomerset Therapeutics, LLC
- Nalbuphine hydrochlorideSomerset Therapeutics, LLC
- Naloxone HydrochlorideSomerset Therapeutics, LLC
- OfloxacinSomerset Therapeutics, LLC
- Phenylephrine HydrochlorideSomerset Therapeutics, LLC
- Pilocarpine Hydrochloride Ophthalmic SolutionSomerset Therapeutics, LLC
- polymyxin b sulfate and trimethoprim sulfateSomerset Therapeutics, LLC
- Potassium PhosphateSomerset Therapeutics, LLC
- Proparacaine HydrochlorideSomerset Therapeutics, LLC
- Ropivacaine Hydrochloridein shortageSomerset Therapeutics, LLC
- Sulfamethoxazole and TrimethoprimSomerset Therapeutics, LLC
- Tetracaine HydrochlorideSomerset Therapeutics, LLC
- Timolol hemihydrateSomerset Therapeutics, LLC
- Timolol maleateSomerset Therapeutics, LLC
- TobramycinSomerset Therapeutics, LLC
- Travoprost (Isomer Free)Somerset Therapeutics, LLC
- TropicamideSomerset Therapeutics, LLC
- Zinc ChlorideSomerset Therapeutics, LLC
- Zinc sulfateSomerset Therapeutics, LLC
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.