Concord Biotech 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
- Unit - II, 297-298 / 2P At Valthera Ta. Dholka, Ahmedabad, Gujarat 382225, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3012520698 · DUNS 650996940
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-03-17
- NAIDrug Quality Assurance2018-02-16
Drugs this plant is listed as making
4 distinct drugs across 9 products name this site in their FDA label.
- mycophenolate mofetilConcord Biotech Limited
- mycophenolic acidConcord Biotech Limited
- TacrolimusConcord Biotech Limited
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.