Cipla 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 β so if this plant has a problem, these are the products that could be affected.
- Country
- India
- Registered address
- Plot D-7, D-22, D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune, Maharashtra 413802, India (IND)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3002806702 Β· DUNS 917066446
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-05-08
- VAIDrug Quality Assurance2019-03-20
- NAIDrug Quality Assurance2018-11-30
- VAIDrug Quality Assurance2016-12-09
- NAIDrug Quality Assurance2014-05-23
- VAIDrug Quality Assurance2011-12-01
- VAIDrug Quality Assurance2009-03-26
Drugs this plant is listed as making
19 distinct drugs across 47 products name this site in their FDA label.
- AbacavirCipla USA Inc.
- arformoterol tartrateCipla USA Inc.
- CelecoxibCipla USA Inc.
- darunavirCipla USA Inc.
- darunavir 600 mgExelan Pharmaceuticals Inc.
- darunavir 800 mgExelan Pharmaceuticals Inc.
- DeferasiroxCipla USA Inc.
- emtricitabineCipla USA Inc.
- Emtricitabine And Tenofovir Disoproxil FumarateCipla USA Inc.
- EntecavirNorthStar RxLLC
- Esomeprazole magnesiumCipla USA Inc.
- Fosfomycin TromethamineCipla USA Inc.
- NintedanibCipla USA Inc.
- pantoprazole sodium granulesCipla USA Inc.
- PREGABALIN capsules, CVCipla USA Inc.
- Sevelamer CarbonateCipla USA Inc.
- Tenofovir disoproxil fumarateCipla USA Inc.
- TopiramateCipla USA 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.