Fdc 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
- B-8,MIDC Industrial Area,Waluj,, Chhatrapati Sambhajinagar, Maharashtra 431136, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3003204330 · DUNS 862267994
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-02-12
- VAIDrug Quality Assurance2018-08-16
- VAIDrug Quality Assurance2016-07-01
- VAIDrug Quality Assurance2014-05-06
- VAIDrug Quality Assurance2012-02-21
Drugs this plant is listed as making
5 distinct drugs across 6 products name this site in their FDA label.
- CiprofloxacinLeading Pharma, LLC
- Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic SolutionLeading Pharma, LLC
- latanoprostRising Pharma Holdings, Inc.
- OfloxacinRising Pharma Holdings, Inc.
- timolol maleateRising Pharma Holdings, 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.