Shilpa Pharma Lifesciences 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.33,33A & 40 to 47, Raichur Industrial Growth Centre, Chicksugur, Raichur, Karnataka 584134, India (IND)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3007197995 · DUNS 915076164
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2025-03-14
- NAIDrug Quality Assurance2020-02-07
- VAIDrug Quality Assurance2019-07-26
- VAIDrug Quality Assurance2016-12-16
- VAIDrug Quality Assurance2015-03-09
- OAIDrug Quality Assurance2013-05-03
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- gemcitabine intravesicalJanssen Biotech, Inc
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.