Gland Pharma 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: 49 & 50, J. N. Pharmacity, Parawada (M), Anakapalli District, Andhra Pradesh 531019, India (IND)
- Operations here
- analysisapi manufacturepack
- FDA identifiers
- FEI 3010142300 · DUNS 860038013
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2024-05-24
- NAIDrug Quality Assurance2023-01-27
- VAIDrug Quality Assurance2018-04-20
- NAIDrug Quality Assurance2015-10-29
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- TigecyclineApotex Corp
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.