Caplin Steriles 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
- SURVEY No.895 & 897. GURUVARAJAKANDIGAI, SIRUPUZHALPETTAI (POST), THIRUVALLUR (DISTRICT), GUMMIDIPOONDI, TAMIL NADU 601201, India (IND)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3005035920 · DUNS 650744670
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBioresearch Monitoring2024-08-09
- VAIDrug Quality Assurance2023-05-31
- VAIDrug Quality Assurance2019-06-14
- NAIDrug Quality Assurance2018-09-06
Drugs this plant is listed as making
55 distinct drugs across 167 products name this site in their FDA label.
- AcetaminophenCaplin Steriles Limited
- ArgatrobanCaplin Steriles Limited
- Brimonidine Tartrate and Timolol MaleateLeading Pharma, LLC
- Calcium GluconateCaplin Steriles Limited
- carboprost tromethamineFresenius Kabi USA, LLC
- Cisatracurium besylateCaplin Steriles Limited
- Desmopressin Acetatein shortageCaplin Steriles Limited
- Dicyclomine HydrochlorideFresenius Kabi USA, LLC
- DifluprednateCaplin Steriles Limited
- Ephedrine SulfateCaplin Steriles Limited
- Etomidatein shortageFresenius Kabi USA, LLC
- Foscarnet SodiumCaplin Steriles Limited
- GatifloxacinLeading Pharma, LLC
- Gatifloxacin Ophthalmic Solution 0.5%Caplin Steriles Limited
- glycopyrrolateBE Pharmaceuticals Inc.
- Haloperidol DecanoateCaplin Steriles Limited
- ketorolac tromethaminein shortageGlenmark Pharmaceuticals Inc., Usa
- Labetalol HydrochlorideNorthStar Rx LLC
- Levetiracetam in Sodium ChlorideSomerset Therapeutics, LLC
- linezolidCaplin Steriles Limited
- MethocarbamolFresenius Kabi USA, LLC
- Methylprednisolone Acetatein shortageCaplin Steriles Limited
- Milrinone LactateSomerset Therapeutics, LLC
- Milrinone Lactate in 5% DextroseSomerset Therapeutics, LLC
- Neostigmine MethylsulfateCaplin Steriles Limited
- Nicardipine HydrochlorideSomerset Therapeutics, LLC
- norepinephrine bitartrateCaplin Steriles Limited
- OfloxacinLeading Pharma, LLC
- Ofloxacin Ophthalmic Solution USP, 0.3%Caplin Steriles Limited
- Ofloxacin OticCaplin Steriles Limited
- Ofloxacin Otic solutionCaplin Steriles Limited
- Phenylephrine HydrochlorideArmas Pharmaceuticals Inc.
- PhytonadioneCaplin Steriles Limited
- Potassium PhosphatesCaplin Steriles Limited
- Procainamide HydrochlorideCaplin Steriles Limited
- Prochlorperazine EdisylateCaplin Steriles Limited
- rocuronium bromidein shortageBE Pharmaceuticals Inc.
- Ropivacaine Hydrochloridein shortageCaplin Steriles Limited
- Sodium NitroprussideCaplin Steriles Limited
- Sodium PhosphatesGlenmark Pharmaceuticals Inc., Usa
- Succinylcholine ChlorideFresenius Kabi USA, LLC
- SumatriptanSomerset Therapeutics, LLC
- Thiamine HydrochlorideNorthStar Rx LLC
- Timolol MaleateCaplin Steriles Limited
- Tranexamic AcidCaplin Steriles Limited
- Verapamil HydrochlorideCaplin Steriles 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.