Home › USFDA Tracker › Syngene International
Syngene International — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Syngene International (NSE: SYNGENE, BSE: 539268), from US FDA records and exchange filings.
90
Compliance score (5 years) · how
3
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 — 20 Feb 2025 (Bengaluru plant). Source: FDA Data Dashboard.
USFDA events by year
2022
2023
2025
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Bengaluru Syngene International Ltd. |
3003600340 | VAI | 20 Feb 2025 | |
| Dakshina Kannada, Mangalore Syngene International Limited |
3012608389 | NAI | 26 May 2023 | |
| Bengalore Syngene International Limited |
3007907068 | NAI | 28 Oct 2022 |
Full USFDA timeline
20 Feb 2025
VAI — minor issues
USFDA inspection classified VAI
Bengaluru · FEI 3003600340 · Syngene International Ltd., Bengaluru — Monitoring of Marketed Animal Drugs, Feed, and Devices (Veterinary)
Source: FDA Data Dashboard ↗
26 May 2023
NAI — clean
USFDA inspection classified NAI
Dakshina Kannada, Mangalore · FEI 3012608389 · Syngene International Limited, Dakshina Kannada, Mangalore — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
15 Nov 2022
NAI — clean
USFDA inspection classified NAI
Bengaluru · FEI 3003600340 · Syngene International Ltd., Bengaluru — Pre-Approval Eval. of Animal Drugs and Food Additives (Veterinary)
Source: FDA Data Dashboard ↗
28 Oct 2022
NAI — clean
USFDA inspection classified NAI
Bengalore · FEI 3007907068 · Syngene International Limited, Bengalore — 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/syngene