Apothecon 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.1134 to 1137,1138 A&B, 1143 A&B,1144 A&B, Padra-Jambusar Highway, At & Post:-Dabhasa, Taluka Padra,, Vadodara, GJ 391440, India (IND)
- Operations here
- analysisapi manufacturemanufacturepack
- FDA identifiers
- FEI 3008405956 · DUNS 650468064
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-01-27
- VAIDrug Quality Assurance2018-08-24
- NAIDrug Quality Assurance2015-10-14
Drugs this plant is listed as making
7 distinct drugs across 10 products name this site in their FDA label.
- Carglumic acidNavinta LLC
- DiazepamNavinta LLC
- famotidineZydus Pharmaceuticals USA Inc.
- Glycerol PhenylbutyrateZydus Pharmaceuticals USA Inc.
- nicardipine hydrochlorideCipla USA Inc.
- PenicillamineNavinta LLC
- Sevelamer carbonateNavinta 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.