Umedica Laboratories 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. 221 and 221/1, GIDC, IInd Phase,, Vapi, Gujarat 396195, India (IND)
- Operations here
- analysismanufacturepack
- FDA identifiers
- FEI 3008460260 · DUNS 920635096
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-03-29
- VAIDrug Quality Assurance2019-07-05
- NAIDrug Quality Assurance2018-01-19
- VAIDrug Quality Assurance2015-10-09
Drugs this plant is listed as making
17 distinct drugs across 87 products name this site in their FDA label.
- Atorvastatin calciumNivagen Pharmaceuticals, Inc.
- CarbamazepineJubilant Cadista Pharmaceuticals Inc.
- CelecoxibUmedica Laboratories USA Inc.
- ChlorthalidoneUmedica Laboratories USA Inc.
- Diclofenac potassiumNivagen Pharmaceuticals, Inc.
- Diclofenac Potassium TabletsUmedica Laboratories USA Inc.
- Diclofenac SodiumUmedica Laboratories USA Inc.
- Fluphenazine HydrochlorideZameer Pharmaceuticals LLC
- MacitentanZydus Pharmaceuticals USA Inc.
- Olmesartan MedoxomilUmedica Laboratories USA Inc.
- Olmesartan Medoxomil and HydrochlorothiazideLifestar Pharma LLC
- OxcarbazepineUmedica Laboratories USA Inc.
- Rosuvastatin CalciumTorrent Pharmaceuticals Limited
- Sertraline hydrochlorideBiocon Pharma Inc.
- Sildenafil CitrateUmedica Laboratories USA Inc.
- TadalafilNivagen Pharmaceuticals, Inc.
- Zolpidem TartrateUmedica Laboratories USA 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.