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Natco Pharma — USFDA Status

Inspections, Form 483 observations, OAI classifications, warning letters, import alerts and approvals for Natco Pharma (NSE: NATCOPHARM, BSE: 524816), 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 — 21 Nov 2025 (Chennai plant). Source: FDA Data Dashboard.
USFDA events by year
2023
2024
2025
2026
NAIVAIForm 483OAIWarning letterImport alertUS approval

Plants

PlantFEILatest resultLast inspectionHistory (newest first)
Chennai
NATCO Pharma Limited
 3009870595 VAI 21 Nov 2025
Rangareddy
NATCO Pharma Limited
 3004540906 VAI 19 Jun 2025
Rangareddy
Natco Pharma Limited
 3004065860 VAI 13 Jun 2025
Hyderabad
NATCO PHARMA LTD
 3017064484 NAI 01 Nov 2023
Anakapalli
Natco Pharma Limited
 3015380536 VAI 03 Feb 2023

Full USFDA timeline

13 Jul 2026
US approval
USFDA tentative approval:
ANDA216768 —
Source: openFDA Drugs@FDA ↗
25 Mar 2026
US approval
USFDA tentative approval:
ANDA217383 —
Source: openFDA Drugs@FDA ↗
19 Mar 2026
US approval
USFDA tentative approval: PALBOCICLIB
ANDA213089 — PALBOCICLIB
Source: openFDA Drugs@FDA ↗
25 Feb 2026
US approval
USFDA tentative approval:
ANDA217441 —
Source: openFDA Drugs@FDA ↗
02 Feb 2026
US approval
USFDA tentative approval: ERDAFITINIB
ANDA218578 — ERDAFITINIB
Source: openFDA Drugs@FDA ↗
21 Nov 2025
VAI — minor issues
USFDA inspection classified VAI
Chennai · FEI 3009870595 · NATCO Pharma Limited, Chennai — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
19 Jun 2025
VAI — minor issues
USFDA inspection classified VAI
Rangareddy · FEI 3004540906 · NATCO Pharma Limited, Rangareddy — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
13 Jun 2025
VAI — minor issues
USFDA inspection classified VAI
Rangareddy · FEI 3004065860 · Natco Pharma Limited, Rangareddy — Drug Quality Assurance (Drugs)
Source: FDA Data Dashboard ↗
05 Mar 2025
US approval
USFDA tentative approval:
ANDA219376 —
Source: openFDA Drugs@FDA ↗
05 Feb 2025
US approval
USFDA approval: BOSENTAN
ANDA213154 — BOSENTAN
Source: openFDA Drugs@FDA ↗
08 Apr 2024
Warning letter
USFDA warning letter
Natco Pharma Limited — CGMP/Finished Pharmaceuticals/Adulterated (close-out issued)
Source: FDA warning letters ↗
01 Nov 2023
NAI — clean
USFDA inspection classified NAI
Hyderabad · FEI 3017064484 · NATCO PHARMA LTD, Hyderabad — Bioresearch Monitoring (Drugs)
Source: FDA Data Dashboard ↗
03 Feb 2023
VAI — minor issues
USFDA inspection classified VAI
Anakapalli · FEI 3015380536 · Natco Pharma Limited, Anakapalli — 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/natco