Glenmark Pharmaceuticals Inc., USA
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
- United States
- Registered address
- 4147 Goldmine Rd, Monroe, North Carolina (NC) 28110, United States (USA)
- Operations here
- analysislabelmanufacturepacksterilize
- FDA identifiers
- FEI 3011585599 · DUNS 079922908
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-06-17
- OAIDrug Quality Assurance2022-05-19
Drugs this plant is listed as making
6 distinct drugs across 16 products name this site in their FDA label.
- Atovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USA
- Atovaquone and Proguanil Hydrochloride PediatricGlenmark Pharmaceuticals Inc.,USA
- FulvestrantGlenmark Pharmaceuticals Inc., Usa
- Naproxen SodiumGlenmark Pharmaceuticals Inc., USA
- Pravastatin SodiumNorthStar RxLLC
- ZonisamideGlenmark Pharmaceuticals Inc., USA
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.