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 — so if this plant has a problem, these are the products that could be affected.
- Country
- India
- Registered address
- Plot No. 9 &10 Indore Special Economic Zone, Phase II - Pithampur, District Dhar, Indore, Madhya Pradesh 454775, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3008581988 · DUNS 918596409
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2023-02-17
- NAIDrug Quality Assurance2019-05-17
- VAIDrug Quality Assurance2018-04-13
- VAIDrug Quality Assurance2015-08-07
- VAIDrug Quality Assurance2013-03-01
- NAIDrug Quality Assurance2012-11-02
Drugs this plant is listed as making
10 distinct drugs across 28 products name this site in their FDA label.
- albuterol sulfateCipla USA Inc.
- Amlodipine BesylateCipla USA Inc.
- arformoterol tartrateCipla USA Inc.
- BudesonideExelan Pharmaceuticals, Inc.
- CelecoxibCipla USA Inc.
- EntecavirNorthStar RxLLC
- FenofibrateCipla USA Inc.
- grisofulvinCipla USA Inc.
- metoprolol succinateBluePoint Laboratories
- SumatriptanCipla 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.