Glenmark Pharmaceuticals 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. 2, Phase-2, Pharma Zone SEZ Pithampur, Dhar, Madhya Pradesh 454775, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3008565058 · DUNS 862603186
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 52 drugs. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2025-02-14
- NAIDrug Quality Assurance2020-02-25
- NAIDrug Quality Assurance2019-09-13
- VAIDrug Quality Assurance2018-05-24
- NAIDrug Quality Assurance2017-08-26
- VAIDrug Quality Assurance2016-02-26
- VAIDrug Quality Assurance2015-07-24
- NAIDrug Quality Assurance2013-10-25
Drugs this plant is listed as making
52 distinct drugs across 159 products name this site in their FDA label.
- Amlodipine and Olmesartan MedoxomilGlenmark Pharmaceuticals Inc., USA
- AprepitantGlenmark Pharmaceuticals Inc., USA
- Asprin And Extended-Release DipyridamoleGlenmark Pharmaceuticals Inc., USA
- Atovaquone and Proguanil HydrochlorideGlenmark Pharmaceuticals Inc.,USA
- Bisoprolol Fumarate and HydrochlorothiazideGlenmark Pharmaceuticals Inc., Usa
- CarvedilolGlenmark Pharmaceuticals Inc., USA
- Chlorpromazine HydrochlorideGlenmark Pharmaceuticals Inc., USA
- Clindamycin HydrochlorideGlenmark Pharmaceuticals Inc., Usa
- colesevelam hydrochlorideGlenmark Pharmaceuticals Inc., USA
- deferasiroxGlenmark Pharmaceuticals Inc., USA
- Diltiazem HydrochlorideGlenmark Pharmaceuticals Inc., Usa
- dimethyl fumarate kitGlenmark Pharmaceuticals Inc., USA
- dimethyl-fumarateGlenmark Pharmaceuticals Inc., USA
- Esomeprazole MagnesiumGlenmark Pharmaceuticals Inc., USA
- EzetimibeGlenmark Pharmaceuticals Inc., USA
- ezetimibe and simvastatinGlenmark Pharmaceuticals Inc., USA
- fenofibrateGlenmark Pharmaceuticals Inc., USA
- fingolimodGlenmark Pharmaceuticals Inc., USA
- Fluphenazine HydrochlorideGlenmark Pharmaceuticals Inc., USA
- frovatriptan succinateGlenmark Pharmaceuticals Inc., USA
- GabapentinGlenmark Pharmaceuticals Inc., USA
- indomethacinGlenmark Pharmaceuticals Inc., USA
- lacosamideGlenmark Pharmaceuticals Inc. USA
- metformin hydrochlorideGlenmark Pharmaceuticals Inc., Usa
- Naproxen SodiumGlenmark Pharmaceuticals Inc., USA
- nebivolol hydrochlorideGlenmark Pharmaceuticals Inc., USA
- Nicardipine HydrochlorideGlenmark Pharmaceuticals Inc., USA
- NitroglycerinGlenmark Pharmaceuticals Inc., USA
- OndansetronGlenmark Pharmaceuticals Inc., USA
- OxcarbazepineGlenmark Pharmaceuticals Inc., USA
- PimecrolimusGlenmark Pharmaceuticals Inc., USA
- Potassium ChlorideNorthstar Rx LLC
- Pravastatin SodiumNorthStar RxLLC
- Prochlorperazine MaleateGlenmark Pharmaceuticals Inc., Usa
- propafenone hydrochlorideGlenmark Pharmaceuticals Inc., USA
- raloxifene hydrochlorideGlenmark Pharmaceuticals Inc., USA
- RanolazineGlenmark Pharmaceuticals Inc., USA
- rufinamideGlenmark Pharmaceuticals Inc., USA
- SaxagliptinGlenmark Pharmaceuticals Inc., USA
- sevelamer hydrochlorideNorthStar RxLLC
- sirolimusGlenmark Pharmaceuticals Inc., USA
- sodium phenylbutyrateGlenmark Pharmaceuticals Inc., Usa
- solifenacin succinateGlenmark Pharmaceuticals Inc., USA
- tacrolimusGlenmark Pharmaceuticals Inc., USA
- Telmisartan and HydrochlorothiazideGlenmark Pharmaceuticals Inc., USA
- teriflunomideGlenmark Pharmaceuticals Inc., USA
- topiramateNorthStar RxLLC
- Trospium ChlorideGlenmark Pharmaceuticals Inc., USA
- voriconazoleGlenmark 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.