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
- B-4\5\6, MIDC Area, Paithan, Chhatrapati Sambhajinagar, Maharashtra 431148, India (IND)
- Operations here
- manufacture
- FDA identifiers
- FEI 3006785788 · DUNS 918594859
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2026-04-21
- NAIDrug Quality Assurance2024-03-05
- VAIDrug Quality Assurance2019-06-28
- VAIDrug Quality Assurance2017-02-07
- VAIDrug Quality Assurance2015-03-20
- VAIDrug Quality Assurance2012-09-06
Drugs this plant is listed as making
28 distinct drugs across 91 products name this site in their FDA label.
- AcetazolamideAjanta Pharma USA Inc.
- almotriptanAjanta Pharma USA Inc.
- Amlodipine besylate and Olmesartan medoxomilAjanta Pharma USA Inc.
- AripiprazoleQuallent Pharmaceuticals Health LLC
- CaptoprilAjanta Pharma USA Inc.
- Clonidine hydrochlorideBluePoint Laboratories
- DuloxetineAjanta Pharma USA Inc.
- EntacaponeAjanta Pharma USA Inc.
- fenofibrateAjanta Pharma USA Inc.
- GuanfacineAjanta Pharma USA Inc.
- LamotrigineAjanta Pharma USA Inc.
- LansoprazoleAjanta Pharma USA Inc.
- Memantine HydrochlorideAjanta Pharma USA Inc.
- Metformin hydrochlorideAjanta Pharma USA Inc.
- MethazolamideAjanta Pharma USA Inc.
- MontelukastAjanta Pharma USA Inc.
- Montelukast SodiumAjanta Pharma USA Inc.
- Omeprazole and Sodium BicarbonateAjanta Pharma USA Inc.
- Oxybutynin ChlorideAjanta Pharma USA Inc.
- Prochlorperazine MaleateAjanta Pharma USA Inc.
- RanitidineAjanta Pharma USA Inc.
- RisperidoneAjanta Pharma USA Inc.
- SildenafilAjanta Pharma USA Inc.
- solifenacin succinateAjanta Pharma USA Inc.
- TadalafilQuallent Pharmaceuticals Health LLC
- VoriconazoleAjanta Pharma USA Inc.
- ZolmitriptanAjanta 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.