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Facility profile

Sun Pharmaceutical Industries Limited

Testing & analysis · Drug product manufacturing · Gujarat 389350 · India

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed11 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

AnalysisManufacture
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Official action indicated (OAI)

Jun 13, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Dec 2022

Within five years · review the action and follow-up.

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Shows

Registration status and a latest matched official action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Review the underlying findings, response, and subsequent follow-up before qualification.

Method and source details
View full inspection and compliance history13 inspection records

FDA inspection history

13 records, Apr 2011 – Jun 2025 · 4 NAI · 4 VAI · 5 OAI

DateClassProject areaCitationsFY
Jun 13, 2025OAIDrug Quality AssuranceYes2025
May 9, 2022OAIDrug Quality AssuranceYes2022
Dec 13, 2019OAIDrug Quality AssuranceYes2020
Jun 11, 2019VAICompliance: Devices2019
Jun 11, 2019NAIDrug Quality Assurance2019
Dec 6, 2018NAIDrug Quality Assurance2019
Aug 31, 2018NAIDrug Quality Assurance2018
Feb 23, 2018VAIDrug Quality AssuranceYes2018
Dec 1, 2016OAIDrug Quality Assurance2017
Sep 16, 2014OAIDrug Quality Assurance2014
Sep 28, 2012VAIDrug Quality Assurance2012
Jun 13, 2012VAIDrug Quality Assurance2012
Apr 7, 2011NAIDrug Quality Assurance2011

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Dec 15, 2022Warning Letter · CDER
Dec 17, 2015Warning Letter · CDER
Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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