Site records / Gujarat / FEI 3003952717

Sun Pharmaceutical Industries LimitedBharuch, Gujarat

FDA-registered drug establishment in Bharuch, Gujarat: analysis, api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
6
Last inspection
Jun 2025 · NAI
Warning letters to this FEI
0
Import alerts at this address
0 of 4 under the name
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

6 FDA inspections of this FEI, by end date; 6 with a posted classification.

  1. 13 Jun 2025NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  2. 8 Nov 2019VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  3. 4 May 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  4. 31 Jul 2015NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  5. 14 Jun 2012VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  6. 26 Feb 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 18 Jun 2024Warning letter to Sun Pharmaceutical Industries Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  2. 16 Oct 2023Warning letter to Sun Pharmaceutical Industries Ltd. SourceCGMP/Active Pharmaceutical Ingredient (API)/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  3. 8 Jun 2022Warning letter to New Sun Inc. SourceUnapproved New Drugs/Misbranded/Cannabidiol (CBD) Products · issued to the firm name; FDA does not tie it to this FEI
  4. 25 Aug 2010Warning letter to Sun Pharmaceutical Industries Inc SourceCGMP for Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
  5. 4 Mar 2010Warning letter to Sun Technologies, Inc. SourceTanning Facility/Federal Performance Standard for Sunlamp Products/Misbranded · issued to the firm name; FDA does not tie it to this FEI

Import alerts in force

Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.

  1. 7 Dec 2022Import alert 66-40 · Published address is another site of this firm SourcePublished address: Halol - Baroda Highway , Halol, Gujarat INDIA
  2. 12 Mar 2014Import alert 66-40 · Published address is not this site SourcePublished address: A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA
  3. 10 Sep 2009Import alert 66-40 · Published address is not this site SourcePublished address: Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA
  4. 10 Sep 2009Import alert 66-40 · Published address is not this site SourcePublished address: 3 Industrial Area , Dewas, Madhya Pradesh INDIA

Other registered sites of Sun Pharmaceutical Industries

Registration

FEI
3003952717
DUNS
918591058
Registered as
Sun Pharmaceutical Industries Limited
Registrant
Sun Pharmaceutical Industries Limited
Address
Plot No 24/2, 25, Phase IV, GIDC, Panoli, Bharuch, Gujarat 394116, India (IND)
Operations
ANALYSIS, API MANUFACTURE
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.

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