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Alembic Pharmaceuticals — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Alembic Pharmaceuticals (NSE: APLLTD, BSE: 533573), from US FDA records and exchange filings.
80
Compliance score (5 years) · how
8
USFDA-inspected plants on record
0
OAI classifications (5y)
2
Form 483s on record (5y)
0
Open warning letters
Latest USFDA record: USFDA inspection classified VAI — 18 Feb 2026 (Vadodara plant). Source: FDA Data Dashboard.
USFDA events by year
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Vadodara Alembic Pharmaceuticals Limited |
3015685305 | VAI | 18 Feb 2026 | |
| Panchmahal Alembic Pharmaceuticals Limited |
3003821360 | VAI | 31 May 2025 | |
| Vadodara Alembic Pharmaceuticals Limited |
3007501748 | NAI | 21 Mar 2025 | |
| Vadodara Alembic Pharmaceuticals Limited |
3016088083 | VAI | 22 Nov 2024 | |
| Panchmahal Alembic Pharmaceuticals Limited |
3004956904 | NAI | 26 Jul 2024 | |
| Panchmahal Alembic Pharmaceuticals Limited |
3014866088 | VAI | 08 Mar 2024 | |
| Vadodara Alembic Pharmaceuticals Limited |
3013826490 | NAI | 10 Mar 2023 | |
| Vadodara Alembic Pharmaceuticals Limited |
3003238213 | NAI | 21 Oct 2022 |
Full USFDA timeline
10 Jun 2026
US approval
USFDA tentative approval: LAROTRECTINIB
ANDA220639 — LAROTRECTINIB
Source: openFDA Drugs@FDA ↗
13 May 2026
18 Feb 2026
VAI — minor issues
USFDA inspection classified VAI
Vadodara · FEI 3015685305 · Alembic Pharmaceuticals Limited, Vadodara — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
31 May 2025
VAI — minor issues
USFDA inspection classified VAI
Panchmahal · FEI 3003821360 · Alembic Pharmaceuticals Limited, Panchmahal — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
21 Mar 2025
NAI — clean
USFDA inspection classified NAI
Vadodara · FEI 3007501748 · Alembic Pharmaceuticals Limited, Vadodara — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
22 Nov 2024
VAI — minor issues
USFDA inspection classified VAI
Vadodara · FEI 3016088083 · Alembic Pharmaceuticals Limited, Vadodara — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
08 Oct 2024
NAI — clean
USFDA inspection classified NAI
Panchmahal · FEI 3003821360 · Alembic Pharmaceuticals Limited, Panchmahal — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
26 Jul 2024
NAI — clean
USFDA inspection classified NAI
Panchmahal · FEI 3004956904 · Alembic Pharmaceuticals Limited, Panchmahal — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
08 Mar 2024
Form 483
Form 483: 1 observation
Panchmahal · FEI 3014866088 · Review of representative number of batches
Source: FDA Data Dashboard (citations) ↗
08 Mar 2024
VAI — minor issues
USFDA inspection classified VAI
Panchmahal · FEI 3014866088 · Alembic Pharmaceuticals Limited, Panchmahal — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
24 Mar 2023
Form 483
Form 483: 1 observation
Vadodara · FEI 3015685305 · Quality control unit review of records
Source: FDA Data Dashboard (citations) ↗
24 Mar 2023
VAI — minor issues
USFDA inspection classified VAI
Vadodara · FEI 3015685305 · Alembic Pharmaceuticals Limited, Vadodara — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
10 Mar 2023
NAI — clean
USFDA inspection classified NAI
Vadodara · FEI 3013826490 · Alembic Pharmaceuticals Limited, Vadodara — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
21 Oct 2022
NAI — clean
USFDA inspection classified NAI
Vadodara · FEI 3003238213 · Alembic Pharmaceuticals Limited, Vadodara — Bioresearch Monitoring (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/alembic-pharma