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
- Specialty Formulation Facility, Plot No: 284B/1, 289-292 Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bengaluru, Karnataka 560105, India (IND)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3007648351 · DUNS 677605290
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-02-24
- VAIDrug Quality Assurance2020-02-28
- VAIDrug Quality Assurance2019-05-13
- VAIDrug Quality Assurance2017-04-18
- VAIDrug Quality Assurance2016-04-13
- OAIDrug Quality Assurance2014-10-03
- OAIDrug Quality Assurance2013-06-27
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- Mycophenolate MofetilMylan Institutional 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.