Manufacturing facility
Zydus Lifesciences 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
- Survey No. 417, 419 and 420, Sarkhej Bavla N. H. No. 8A Village-Moraiya, Taluka-Sanand Ahmedabad, Ahmedabad, Gujarat 382210, India (IND)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3002984011 · DUNS 918596198
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2022-08-05
- OAIDrug Quality Assurance2019-05-03
- NAIBioresearch Monitoring2019-03-22
- NAIDrug Quality Assurance2018-02-09
- NAIDrug Quality Assurance2017-02-16
- OAIDrug Quality Assurance2014-09-05
- VAIDrug Quality Assurance2013-08-19
- VAIDrug Quality Assurance2012-02-23
- OAIDrug Quality Assurance2011-02-03
- NAIDrug Quality Assurance2009-02-06
Drugs this plant is listed as making
88 distinct drugs across 449 products name this site in their FDA label.
- acetazolamideZydus Lifesciences Limited
- AcyclovirZydus Pharmaceuticals (USA) Inc.
- amiodarone hydrochlorideZydus Pharmaceuticals USA Inc.
- Amlodipine BesylateZydus Pharmaceuticals USA Inc.
- AnastrozoleZydus Lifesciences Limited
- AtenololZydus Lifesciences Limited
- atomoxetineZydus Pharmaceuticals USA Inc.
- AzathioprineZydus Lifesciences Limited
- BenzonatateZydus Lifesciences Limited
- Bromocriptine mesylateZydus Lifesciences Limited
- bupropionZydus Lifesciences Limited
- Buspirone hydrochlorideZydus Pharmaceuticals USA Inc.
- Candesartan cilexetilZydus Lifesciences Limited
- candesartan cilexetil and hydrochlorothiazideZydus Lifesciences Limited
- carbamazepineZydus Pharmaceuticals (USA) Inc.
- CarvedilolZydus Lifesciences Limited
- DipyridamoleZydus Lifesciences Limited
- Divalproex SodiumBluePoint Laboratories
- doxepinViona Pharmaceuticals Inc
- DoxycyclineZydus Lifesciences Limited
- DuloxetineZydus Lifesciences Limited
- Dutasteride and tamsulosin hydrochlorideZydus Pharmaceuticals USA Inc.
- ErythromycinZydus Lifesciences Limited
- Esomeprazole MagnesiumZydus Pharmaceuticals USA Inc.
- EstradiolZydus Lifesciences Limited
- EtodolacZydus Lifesciences Limited
- ezetimibeZydus Pharmaceuticals USA Inc.
- febuxostatViona Pharmaceuticals Inc
- fesoterodine fumarateZydus Pharmaceuticals USA Inc.
- fluconazoleZydus Lifesciences Limited
- Fludrocortisone acetateViona Pharmaceuticals Inc
- GabapentinZydus Pharmaceuticals USA Inc.
- GemfibrozilViona Pharmaceuticals Inc
- GlipizideNorthstar Rx LLC.
- Glipizide and Metformin HydrochlorideZydus Lifesciences Limited
- HaloperidolZydus Pharmaceuticals USA Inc.
- Hydroxychloroquine sulfateZydus Lifesciences Limited
- IsotretinoinZydus Lifesciences Limited
- ketorolac tromethaminein shortageZydus Lifesciences Limited
- LamotrigineZydus Lifesciences Limited
- LansoprazoleZydus Lifesciences Limited
- levofloxacinViona Pharmaceuticals Inc
- Losartan PotassiumZydus Lifesciences Limited
- LubiprostoneZydus Pharmaceuticals USA Inc.
- meloxicamZydus Pharmaceuticals USA Inc.
- Memantine HydrochlorideZydus Lifesciences Limited
- mesalamineZydus Pharmaceuticals USA Inc.
- Metformin HydrochlorideZydus Lifesciences Limited
- methylprednisoloneZydus Lifesciences Limited
- NifedipineZydus Lifesciences Limited
- nitrofurantoin macrocrystalsZydus Pharmaceuticals (USA) Inc.
- norelgestromin and ethinyl estradiolZydus Pharmaceuticals USA Inc.
- Nortriptyline HydrochlorideZydus Lifesciences Limited
- OmeprazoleZydus Lifesciences Limited
- oseltamivir phosphateZydus Pharmaceuticals USA Inc.
- oxybutyninZydus Pharmaceuticals USA Inc.
- ParoxetineZydus Pharmaceuticals USA Inc.
- Paroxetine HydrochlorideZydus Lifesciences Limited
- pitavastatin calciumZydus Lifesciences Limited
- Pitavastatin MagnesiumZydus Lifesciences Limited
- Promethazine Hydrochloridein shortageZydus Lifesciences Limited
- RamiprilZydus Lifesciences Limited
- risperidoneZydus Pharmaceuticals USA Inc.
- sacubitril and valsartanZydus Pharmaceuticals USA Inc.
- sirolimusZydus Pharmaceuticals USA Inc.
- SitagliptinZydus Lifesciences Limited
- Sitagliptin and Metformin HydrochlorideZydus Lifesciences Limited
- Succinylcholine ChlorideZydus Lifesciences Limited
- TadalafilZydus Lifesciences Limited
- Tamsulosin HydrochlorideZydus Pharmaceuticals USA Inc.
- telmisartanZydus Pharmaceuticals USA Inc.
- tofacitinibZydus Lifesciences Limited
- TopiramateZydus Lifesciences Limited
- TriazolamZydus Pharmaceuticals USA Inc.
- valsartan and hydrochlorothiazideZydus Lifesciences Limited
- VenlafaxineZydus Pharmaceuticals USA Inc.
- Venlafaxine HydrochlorideZydus Pharmaceuticals USA Inc.
- vigabatrinZydus Pharmaceuticals (USA) Inc.
- ZolmitriptanZydus Pharmaceuticals USA Inc.
- ZonisamideViona Pharmaceuticals 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.