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Alkem Laboratories — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Alkem Laboratories (NSE: ALKEM, BSE: 539523), from US FDA records and exchange filings.

80
Compliance score (5 years) · how
4
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 — 27 Mar 2024 (Tehsil Nalagarh, Baddi plant). Source: FDA Data Dashboard.
USFDA events by year
2022
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval

Plants

PlantFEILatest resultLast inspectionHistory (newest first)
Tehsil Nalagarh, Baddi
Alkem Laboratories Limited
 3006370533 VAI 27 Mar 2024
Ankleshwar
Alkem Laboratories Limited
 3008450172 VAI 01 Dec 2023
Ankleshwar
Alkem Laboratories Limited
 3006851796 NAI 07 Apr 2023
Navi Mumbai
Alkem Laboratories Ltd., Bioequivalence Centre
 3004438419 NAI 14 Apr 2022

Full USFDA timeline

24 Mar 2026
US approval
USFDA tentative approval:
ANDA220352 —
Source: openFDA Drugs@FDA ↗
20 Mar 2026
US approval
USFDA tentative approval: RIFAXIMIN
ANDA220451 — RIFAXIMIN
Source: openFDA Drugs@FDA ↗
04 Nov 2025
US approval
USFDA tentative approval:
ANDA219416 —
Source: openFDA Drugs@FDA ↗
23 Oct 2025
US approval
USFDA tentative approval: BEMPEDOIC ACID AND EZETIMIBE
ANDA219421 — BEMPEDOIC ACID, EZETIMIBE
Source: openFDA Drugs@FDA ↗
27 Mar 2024
VAI — minor issues
USFDA inspection classified VAI
Tehsil Nalagarh, Baddi · FEI 3006370533 · Alkem Laboratories Limited, Tehsil Nalagarh, Baddi — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
01 Dec 2023
VAI — minor issues
USFDA inspection classified VAI
Ankleshwar · FEI 3008450172 · Alkem Laboratories Limited, Ankleshwar — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
07 Apr 2023
NAI — clean
USFDA inspection classified NAI
Ankleshwar · FEI 3006851796 · Alkem Laboratories Limited, Ankleshwar — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
14 Apr 2022
NAI — clean
USFDA inspection classified NAI
Navi Mumbai · FEI 3004438419 · Alkem Laboratories Ltd., Bioequivalence Centre, Navi Mumbai — 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/alkem