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Emcure Pharmaceuticals — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Emcure Pharmaceuticals (NSE: EMCURE), from US FDA records and exchange filings.
70
Compliance score (5 years) · how
5
USFDA-inspected plants on record
0
OAI classifications (5y)
1
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 15 May 2026 (Ahmedabad plant). Source: FDA Data Dashboard.
USFDA events by year
2015
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Ahmedabad Emcure Pharmaceuticals Limited |
3014595023 | VAI | 15 May 2026 | |
| Surendranagar Emcure Pharmaceuticals Ltd. |
3022175565 | NAI | 10 Oct 2025 | |
| Pune Emcure Pharmaceuticals Limited |
3005782879 | VAI | 25 Feb 2025 | |
| Pune Emcure Pharmaceuticals Limited |
3006643860 | NAI | 31 Mar 2023 | |
| Gandhinagar Emcure Pharmaceuticals Limited |
3016408148 | NAI | 24 Jun 2022 |
Full USFDA timeline
15 May 2026
VAI — minor issues
USFDA inspection classified VAI
Ahmedabad · FEI 3014595023 · Emcure Pharmaceuticals Limited, Ahmedabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
10 Oct 2025
NAI — clean
USFDA inspection classified NAI
Surendranagar · FEI 3022175565 · Emcure Pharmaceuticals Ltd., Surendranagar — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
12 Jun 2025
US approval
USFDA tentative approval: DOLUTEGRAVIR AND LAMIVUDINE
ANDA219623 — DOLUTEGRAVIR AND LAMIVUDINE
Source: openFDA Drugs@FDA ↗
25 Feb 2025
VAI — minor issues
USFDA inspection classified VAI
Pune · FEI 3005782879 · Emcure Pharmaceuticals Limited, Pune — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
05 Dec 2024
US approval
USFDA tentative approval: ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE
ANDA212181 — ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE
Source: openFDA Drugs@FDA ↗
13 Nov 2024
05 Apr 2024
Form 483
Form 483: 1 observation
Ahmedabad · FEI 3014595023 · Establishment of calibration procedures
Source: FDA Data Dashboard (citations) ↗
05 Apr 2024
VAI — minor issues
USFDA inspection classified VAI
Ahmedabad · FEI 3014595023 · Emcure Pharmaceuticals Limited, Ahmedabad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
31 Mar 2023
NAI — clean
USFDA inspection classified NAI
Pune · FEI 3006643860 · Emcure Pharmaceuticals Limited, Pune — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
24 Jun 2022
NAI — clean
USFDA inspection classified NAI
Gandhinagar · FEI 3016408148 · Emcure Pharmaceuticals Limited, Gandhinagar — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
13 Jul 2015
Import alert
Added to FDA import alert 66-40
Emcure Pharmaceuticals Limited, Plot No. P-2, I.T.B.T. Park, Phase - II, MIDC, Hinjawadi, Pune, Maharashtra INDIA
Source: FDA import alerts ↗
📎 Cite this data: Source: PharmaRoz analysis of FDA inspection data and exchange filings, updated 12 Nov 2026 — https://pharmaroz.com/company/emcure