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Ajanta Pharma — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Ajanta Pharma (NSE: AJANTPHARM, BSE: 532331), from US FDA records and exchange filings.

87
Compliance score (5 years) · how
2
USFDA-inspected plants on record
0
OAI classifications (5y)
0
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 21 Apr 2026 (Paithan plant). Source: FDA Data Dashboard.
USFDA events by year
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval

Plants

PlantFEILatest resultLast inspectionHistory (newest first)
Paithan
Ajanta Pharma Ltd.
 3006785788 VAI 21 Apr 2026
Bharuch
Ajanta Pharma Limited
 3012664809 NAI 23 Jun 2023

Full USFDA timeline

19 Oct 2026
US approval
USFDA approval: TOFACITINIB CITRATE
ANDA219542 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
14 Sep 2026
US approval
USFDA approval: HALOPERIDOL
ANDA218210 — HALOPERIDOL
Source: openFDA Drugs@FDA ↗
16 Jul 2026
US approval
USFDA tentative approval: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA215220 — METFORMIN HYDROCHLORIDE, SITAGLIPTIN
Source: openFDA Drugs@FDA ↗
09 Jul 2026
US approval
USFDA tentative approval: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA216516 — METFORMIN HYDROCHLORIDE, SITAGLIPTIN
Source: openFDA Drugs@FDA ↗
21 Apr 2026
VAI — minor issues
USFDA inspection classified VAI
Paithan · FEI 3006785788 · Ajanta Pharma Ltd., Paithan — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
07 Apr 2026
US approval
USFDA approval: IVERMECTIN
ANDA218509 — IVERMECTIN
Source: openFDA Drugs@FDA ↗
06 Apr 2026
US approval
USFDA approval: DAPAGLIFLOZIN
ANDA211482 — DAPAGLIFLOZIN
Source: openFDA Drugs@FDA ↗
20 Mar 2026
US approval
USFDA approval: TOFACITINIB CITRATE
ANDA212943 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
25 Feb 2026
US approval
USFDA tentative approval: EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA220511 — EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
24 Feb 2026
US approval
USFDA tentative approval: SITAGLIPTIN PHOSPHATE
ANDA214784 — SITAGLIPTIN PHOSPHATE
Source: openFDA Drugs@FDA ↗
09 Feb 2026
US approval
USFDA approval: METHAZOLAMIDE
ANDA217408 — METHAZOLAMIDE
Source: openFDA Drugs@FDA ↗
16 Jan 2026
US approval
USFDA approval: PRUCALOPRIDE SUCCINATE
ANDA219220 — PRUCALOPRIDE SUCCINATE
Source: openFDA Drugs@FDA ↗
02 Sep 2025
US approval
USFDA approval: TOPIRAMATE
ANDA219564 — TOPIRAMATE
Source: openFDA Drugs@FDA ↗
19 Aug 2025
US approval
USFDA approval: TOFACITINIB CITRATE
ANDA219542 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
12 May 2025
US approval
USFDA approval: TERAZOSIN HYDROCHLORIDE
ANDA219482 — TERAZOSIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
11 Apr 2025
US approval
USFDA tentative approval: EMPAGLIFLOZIN
ANDA217055 — EMPAGLIFLOZIN
Source: openFDA Drugs@FDA ↗
26 Mar 2025
US approval
USFDA approval: THEOPHYLLINE
ANDA218401 — THEOPHYLLINE
Source: openFDA Drugs@FDA ↗
24 Feb 2025
US approval
USFDA tentative approval:
ANDA217353 —
Source: openFDA Drugs@FDA ↗
23 Jan 2025
US approval
USFDA tentative approval:
ANDA217781 —
Source: openFDA Drugs@FDA ↗
13 Jan 2025
US approval
USFDA approval: THEOPHYLLINE
ANDA218401 — THEOPHYLLINE
Source: openFDA Drugs@FDA ↗
17 Oct 2024
US approval
USFDA approval: FLUVOXAMINE MALEATE
ANDA219055 — FLUVOXAMINE MALEATE
Source: openFDA Drugs@FDA ↗
01 Jul 2024
US approval
USFDA approval: DOXEPIN HYDROCHLORIDE
ANDA218564 — DOXEPIN HYDROCHLORIDE
Source: openFDA Drugs@FDA ↗
26 Jun 2024
US approval
USFDA approval: PALIPERIDONE
ANDA218514 — PALIPERIDONE
Source: openFDA Drugs@FDA ↗
09 May 2024
US approval
USFDA approval: PROCHLORPERAZINE MALEATE
ANDA218515 — PROCHLORPERAZINE MALEATE
Source: openFDA Drugs@FDA ↗
19 Mar 2024
US approval
USFDA approval: VARENICLINE TARTRATE
ANDA213019 — VARENICLINE TARTRATE
Source: openFDA Drugs@FDA ↗
05 Mar 2024
NAI — clean
USFDA inspection classified NAI
Paithan · FEI 3006785788 · Ajanta Pharma Ltd., Paithan — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
22 Feb 2024
US approval
USFDA approval: OXCARBAZEPINE
ANDA217659 — OXCARBAZEPINE
Source: openFDA Drugs@FDA ↗
23 Jun 2023
NAI — clean
USFDA inspection classified NAI
Bharuch · FEI 3012664809 · Ajanta Pharma Limited, Bharuch — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/ajanta