Home › USFDA Tracker › Concord Biotech
Concord Biotech — USFDA Status
Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Concord Biotech (NSE: CONCORDBIO), from US FDA records and exchange filings.
73
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 — 02 May 2025 (Ahmedabad, Gujarat State plant). Source: FDA Data Dashboard.
USFDA events by year
2023
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval
Plants
| Plant | FEI | Latest result | Last inspection | History (newest first) |
|---|---|---|---|---|
| Ahmedabad, Gujarat State Concord Biotech Limited |
3004126703 | VAI | 02 May 2025 | |
| Kheda CONCORD BIOTECH LIMITED |
3020052335 | NAI | 30 Jun 2023 | |
| Ahmedabad CONCORD BIOTECH LIMITED |
3012520698 | VAI | 17 Mar 2023 |
Full USFDA timeline
09 Jun 2026
US approval
USFDA approval: TOFACITINIB CITRATE
ANDA218821 — TOFACITINIB CITRATE
Source: openFDA Drugs@FDA ↗
02 May 2025
VAI — minor issues
USFDA inspection classified VAI
Ahmedabad, Gujarat State · FEI 3004126703 · Concord Biotech Limited, Ahmedabad, Gujarat State — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
30 Jun 2023
NAI — clean
USFDA inspection classified NAI
Kheda · FEI 3020052335 · CONCORD BIOTECH LIMITED, Kheda — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
17 Mar 2023
VAI — minor issues
USFDA inspection classified VAI
Ahmedabad · FEI 3012520698 · CONCORD BIOTECH LIMITED, Ahmedabad — 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/concord-biotech