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Unichem Laboratories — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Unichem Laboratories (NSE: UNICHEMLAB, BSE: 506690), from US FDA records and exchange filings.
68
Compliance score (5 years) · how
5
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 — 02 Feb 2026 (Hupari plant). Source: FDA Data Dashboard.
USFDA events by year
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Hupari Unichem Laboratories Limited |
3013585679 | VAI | 02 Feb 2026 | |
| District Raigad Unichem Laboratories Ltd |
3004373180 | VAI | 20 Jun 2025 | |
| Pithampur Unichem Laboratories Limited |
3006456888 | VAI | 28 Feb 2025 | |
| Pilerne Bardez Unichem Laboratories Limited |
3005497507 | VAI | 15 Jul 2024 | |
| Ghaziabad Unichem Laboratories Ltd. |
3004082076 | NAI | 13 Feb 2024 |
Full USFDA timeline
29 Sep 2026
US approval
USFDA tentative approval: SOLRIAMFETOL
ANDA218761 — SOLRIAMFETOL
Source: openFDA Drugs@FDA ↗
02 Feb 2026
VAI — minor issues
USFDA inspection classified VAI
Hupari · FEI 3013585679 · Unichem Laboratories Limited, Hupari — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
20 Jun 2025
VAI — minor issues
USFDA inspection classified VAI
District Raigad · FEI 3004373180 · Unichem Laboratories Ltd, District Raigad — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
28 Feb 2025
VAI — minor issues
USFDA inspection classified VAI
Pithampur · FEI 3006456888 · Unichem Laboratories Limited, Pithampur — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
15 Jul 2024
VAI — minor issues
USFDA inspection classified VAI
Pilerne Bardez · FEI 3005497507 · Unichem Laboratories Limited, Pilerne Bardez — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
13 Feb 2024
NAI — clean
USFDA inspection classified NAI
Ghaziabad · FEI 3004082076 · Unichem Laboratories Ltd., Ghaziabad — 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/unichem