Alkem Laboratories 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
- Srv. No. 167, Plot No. 164, 165/1, 165/2, 165/3, 168/215, 168/216, 168/234, Village Dabhel, Daman, Dadra & Nagar Haveli and Daman & Diu 396210, India (IND)
- Operations here
- analysismanufacturepackrepack
- FDA identifiers
- FEI 3006370524 · DUNS 915628612
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2019-08-30
- NAIDrug Quality Assurance2019-01-18
- VAIDrug Quality Assurance2018-03-27
- VAIDrug Quality Assurance2016-09-29
- VAIDrug Quality Assurance2013-10-25
- VAIDrug Quality Assurance2011-12-09
Drugs this plant is listed as making
56 distinct drugs across 180 products name this site in their FDA label.
- Amlodipine besylateAscend Laboratories, LLC
- AripiprazoleAscend Laboratories, LLC
- Atorvastatin CalciumAscend Laboratories, LLC
- AzelastineAscend Laboratories, LLC
- BrivaracetamAscend Laboratories, LLC
- Brompheniramine, Pseudoephedrine, DextromethorphanAscend Laboratories, LLC
- cefdinirAscend Laboratories, LLC
- CefiximeAscend Laboratories, LLC
- Cefpodoxime ProxetilAmici Pharmaceuticals, LLC.
- CefprozilAscend Laboratories, LLC
- Cefuroxime axetilAscend Laboratories, LLC
- CephalexinAscend Laboratories, LLC
- Clopidogrel BisulfateAscend Laboratories, LLC
- Dabigatran EtexilateMajor Pharmaceuticals
- DeferasiroxAscend Laboratories, LLC
- Dexmethylphenidate HydrochlorideAscend Laboratories, LLC
- DuloxetineAscend Laboratories, LLC
- Esomeprazole magnesiumAscend Laboratories, LLC
- Esomeprazole magnesium delayed release capsulesAscend Laboratories, LLC
- FebuxostatAscend Laboratories, LLC
- GabapentinAscend Laboratories, LLC
- Hydralazine HydrochlorideAscend Laboratories, LLC
- ItraconazoleAscend Laboratories, LLC
- LacosamideAscend Laboratories, LLC
- Lacosamide Oral SolutionAscend Laboratories, LLC
- LamotrigineAscend Laboratories, LLC
- LansoprazoleAscend Laboratories, LLC
- Lanthanum CarbonateAscend Laboratories, LLC
- LinezolidAscend Laboratories, LLC
- MesalamineAscend Laboratories, LLC
- Metformin HydrochlorideAscend Laboratories, LLC
- Methylphenidate Hydrochloridein shortageAscend Laboratories, LLC
- Metoprolol Succinate ER TabletsAscend Laboratories, LLC
- Minocycline HydrochlorideAscend Laboratories, LLC
- NebivololAscend Laboratories, LLC
- OlanzapineAscend Laboratories, LLC
- OxcarbazepineAscend Laboratories, LLC
- PregabalinAscend Laboratories, LLC
- RasagilineNorthStar RxLLC
- RivaroxabanAscend Laboratories, LLC
- Rizatriptan BenzoateAscend Laboratories, LLC
- RoflumilastAscend Laboratories, LLC
- RosuvastatinQuallent Pharmaceuticals Health LLC
- Rosuvastatin CalciumAscend Laboratories, LLC
- Sacubitril and ValsartanAscend Laboratories, LLC
- Solifenacin SuccinateAscend Laboratories, LLC
- Tamsulosin HydrochlorideAscend Laboratories, LLC
- TizanidineAscend Laboratories, LLC
- Tizanidne hydrochlorideAscend Laboratories, LLC
- TolvaptanAscend Laboratories, LLC
- TopiramateAscend Laboratories, LLC
- ValsartanAscend Laboratories, LLC
- Vancomycin HydrochlorideAscend Laboratories, LLC
- VigabatrinAscend Laboratories, LLC
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.