Mylan Laboratories 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
- (FDF-1), F-4 and F-12, Malegaon MIDC, Sinnar, Nasik District, Nashik, Maharashtra 422113, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3005587313 · DUNS 725584960
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2020-02-07
- NAIDrug Quality Assurance2019-01-18
- VAIDrug Quality Assurance2018-04-12
- OAIDrug Quality Assurance2016-09-14
- VAIDrug Quality Assurance2015-03-25
- NAIDrug Quality Assurance2012-08-30
- VAIDrug Quality Assurance2011-05-27
- NAIDrug Quality Assurance2009-08-08
Drugs this plant is listed as making
1 distinct drugs across 3 products name this site in their FDA label.
- paliperidoneArchis Pharma 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.