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
- Khasra No 1544, 1553, 1558, 1559 Village Thana, Tehsil Nalagarh, Baddi, Himachal Pradesh 173205, India (IND)
- Operations here
- analysismanufacturepackrepack
- FDA identifiers
- FEI 3006370533 · DUNS 677605851
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-03-27
- VAIDrug Quality Assurance2020-02-21
- VAIDrug Quality Assurance2019-11-26
- VAIDrug Quality Assurance2019-05-17
- VAIDrug Quality Assurance2017-03-10
- VAIDrug Quality Assurance2015-07-31
- NAIDrug Quality Assurance2013-09-20
- NAIDrug Quality Assurance2012-08-31
- VAIDrug Quality Assurance2009-11-06
Drugs this plant is listed as making
48 distinct drugs across 127 products name this site in their FDA label.
- Amlodipine and olmesartan MedoxomilAscend Laboratories, LLC
- Amlodipine besylateAscend Laboratories, LLC
- AzathioprineAscend Laboratories, LLC
- CapecitabineCivicaScript LLC
- CarbamazepineAscend Laboratories, LLC
- Chlordiazepoxide Hydrochloride and Clidinium BromideAscend Laboratories, LLC
- ChlorthalidoneAscend Laboratories, LLC
- CinacalcetAscend Laboratories, LLC
- ClobazamAscend Laboratories, LLC
- Clopidogrel BisulfateAscend Laboratories, LLC
- Colesevelam hydrochlorideAscend Laboratories, LLC
- DalfampridineCivicaScript LLC
- dapagliflozin and metformin hydrochlorideAscend Laboratories, LLC
- Diclofenac PotassiumAscend Laboratories, LLC
- Dimethyl fumarateAscend Laboratories, LLC
- DroxidopaCivicaScript LLC
- ErythromycinAscend Laboratories, LLC
- Eslicarbazepine AcetateAscend Laboratories, LLC
- EverolimusAscend Laboratories, LLC
- EzetimibeAscend Laboratories, LLC
- Ezetimibe and SimvastatinAscend Laboratories, LLC
- FinasterideThirty Madison Inc
- FingolimodCivicaScript LLC
- Fingolimod hydrochlorideAscend Laboratories, LLC
- Fosfomycin TromethamineAscend Laboratories, LLC
- GabapentinAscend Laboratories, LLC
- LevetiracetamAscend Laboratories, LLC
- lurasidone hydrochlorideAscend Laboratories, LLC
- Metformin HydrochlorideAscend Laboratories, LLC
- Methylphenidate Hydrochloridein shortageAscend Laboratories, LLC
- Mycophenolate MofetilAscend Laboratories, LLC
- Mycophenolic AcidAscend Laboratories, LLC
- NifedipineAscend Laboratories, LLC
- Olmesartan MedoxomilAscend Laboratories, LLC
- Olmesartan Medoxomil And HydrochlorothiazideAscend Laboratories, LLC
- Rabeprazole SodiumAscend Laboratories, LLC
- RanolazineAscend Laboratories, LLC
- Sildenafil CitrateAscend Laboratories, LLC
- SirolimusAscend Laboratories, LLC
- Solifenacin SuccinateAscend Laboratories, LLC
- TacrolimusAscend Laboratories, LLC
- TicagrelorAscend Laboratories, LLC
- varenicline tartrateMajor Pharmaceuticals
- VenlafaxineAscend 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.