Ajanta Pharma 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. Z-103 /A Dahej SEZ - Part II, Bharuch, Gujarat 392130, India (IND)
- Operations here
- manufacture
- FDA identifiers
- FEI 3012664809 · DUNS 862199968
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2023-06-23
- VAIDrug Quality Assurance2019-06-22
- NAIDrug Quality Assurance2018-02-09
Drugs this plant is listed as making
36 distinct drugs across 102 products name this site in their FDA label.
- almotriptanAjanta Pharma USA Inc.
- BrexpiprazoleAjanta Pharma USA Inc.
- CarbamazepineAjanta Pharma USA Inc.
- ChlorthalidoneAjanta Pharma USA Inc.
- CholestyramineAjanta Pharma USA Inc.
- Clomipramine hydrochlorideAjanta Pharma USA Inc.
- DapagliflozinAjanta Pharma USA Inc.
- Divalproex sodiumAjanta Pharma USA Inc.
- Doxycycline hyclateAjanta Pharma USA Inc.
- DuloxetineQuallent Pharmaceuticals Health LLC
- FamotidineAjanta Pharma USA Inc.
- fenofibrateAjanta Pharma USA Inc.
- Fluphenazine hydrochlorideAjanta Pharma USA Inc.
- Fluvoxamine MaleateAjanta Pharma USA Inc.
- IvermectinAjanta Pharma USA Inc.
- Montelukast SodiumAjanta Pharma USA Inc.
- Naproxen and esomeprazole magnesiumAjanta Pharma USA Inc.
- Omeprazole and Sodium BicarbonateAjanta Pharma USA Inc.
- Oseltamivir phosphateAjanta Pharma USA Inc.
- OxcarbazepineAjanta Pharma USA Inc.
- Pantoprazole sodiumAjanta Pharma USA Inc.
- RanolazineAjanta Pharma USA Inc.
- RisperidoneAjanta Pharma USA Inc.
- SildenafilAjanta Pharma USA Inc.
- SilodosinAjanta Pharma USA Inc.
- TadalafilAjanta Pharma USA Inc.
- TerazosinAjanta Pharma USA Inc.
- TetrabenazineAjanta Pharma USA Inc.
- TheophyllineAjanta Pharma USA Inc.
- Tolterodine tartrateAjanta Pharma USA Inc.
- TopiramateAjanta Pharma USA Inc.
- ValganciclovirAjanta Pharma USA Inc.
- Valganciclovir hydrochlorideAjanta Pharma USA Inc.
- VenlafaxineAjanta Pharma USA 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.