Medley Pharmaceuticals 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. 18 AND 19, ZARI CAUSEWAY ROAD, KACHIGAM, DAMAN, DAMAN AND DIU 396210, India (IND)
- Operations here
- manufacture
- FDA identifiers
- FEI 3006896204 · DUNS 677602480
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-05-19
- VAIDrug Quality Assurance2018-12-14
- VAIDrug Quality Assurance2016-02-19
Drugs this plant is listed as making
4 distinct drugs across 18 products name this site in their FDA label.
- LacosamideKanchan Healthcare Inc
- NystatinLeading Pharma, LLC
- OxcarbazepineKanchan Healthcare Inc
- Varenicline TartrateLeading 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.