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Manufacturing facility

Apicore 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
Block No. 252-253, Village - Dhobikuva, Opposite Jain Irrigation, Padra - Jambusar Highway, Tal. Padra., Vadodara, Gujarat 391440, India (IND)
Operations here
analysisapi manufacturerelabelrepacksterilize
FDA identifiers
FEI 3006767695 · DUNS 676248879

FDA inspection history

Outcomes of closed FDA inspections at this site (drug and biologic program areas).

  • VAIDrug Quality Assurance2023-05-05
  • NAIDrug Quality Assurance2019-11-08
  • VAIDrug Quality Assurance2018-01-25
  • VAIDrug Quality Assurance2016-03-25
  • VAIDrug Quality Assurance2014-06-13
  • VAIDrug Quality Assurance2011-09-12

Drugs this plant is listed as making

1 distinct drugs across 4 products name this site in their FDA label.

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.