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Manufacturing facility

Rubicon Research 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 K-30/4 & K30/5, MIDC, Additional Ambernath Area,, Thane, Maharashtra 421 506, India (IND)
Operations here
analysislabelmanufacturepack
FDA identifiers
FEI 3008252295 · DUNS 677604197

FDA inspection history

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

  • NAIDrug Quality Assurance2024-03-08
  • VAIDrug Quality Assurance2023-01-27
  • NAIDrug Quality Assurance2017-11-20
  • NAIDrug Quality Assurance2015-03-13
  • VAIDrug Quality Assurance2013-04-11

Drugs this plant is listed as making

53 distinct drugs across 204 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.