Site records / Telangana / FEI 3004540906

Natco Pharma LimitedRangareddy, Telangana

FDA-registered drug establishment in Rangareddy, Telangana: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted: 7
Last inspection: Jun 2025 · VAI
Warning letters to this FEI: 1
Import alerts at this address: 0
US border refusals, 2 years: 0

The site dossier

This site, graded.
Every fact sourced.

A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
Warning-letter violations, numbered and labelled
Import-alert history rebuilt from the archive, each listing checked against this address
Border refusals by product, and the company's other sites, each graded
A hash of every source read, so the PDF can be checked against the record

On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.

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Inspections

7 FDA inspections of this FEI, by end date; 7 with a posted classification.

19 Jun 2025VAI · Voluntary Action IndicatedDrug Quality Assurance · 7 citations posted
24 Jun 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
6 Jun 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
24 Jan 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · 6 citations posted
23 May 2014VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
18 Nov 2011NAI · No Action IndicatedDrug Quality Assurance · no citations posted
12 Feb 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

8 Apr 2024Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated

Import alerts in force

No listing in force under this firm's name.

Form 483s released by FDA

24 Jan 2017Form 483 · 6 pages Source
18 Oct 2023Form 483 · 27 pages Source
19 Jun 2025Form 483 · 9 pages Source

Other registered sites of Natco Pharma

Natco Pharma LimitedRangareddy, Telangana
Natco Pharma LimitedChennai, Tamil Nadu
Natco Pharma LimitedAnakapalli, Andhra Pradesh

Registration

FEI: 3004540906
DUNS: 918588174
Registered as: NATCO PHARMA LIMITED
Registrant: NATCO PHARMA LIMITED
Address: Pharma Division, Kothur, Rangareddy, Telangana 509228, India (IND)
Operations: ANALYSIS, LABEL, MANUFACTURE, PACK
Registration expires: 31 Dec 2026

Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.