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Facility profile

Glenmark Pharmaceuticals Limited

Testing & analysis · Drug product manufacturing · Madhya Pradesh 454775 · India

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed9 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.

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Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Official action indicated (OAI)

Feb 14, 2025 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Jul 2025

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 history8 inspection records

FDA inspection history

8 records, Oct 2013 – Feb 2025 · 4 NAI · 3 VAI · 1 OAI

DateClassProject areaCitationsFY
Feb 14, 2025OAIDrug Quality AssuranceYes2025
Feb 25, 2020NAIDrug Quality Assurance2020
Sep 13, 2019NAIDrug Quality Assurance2019
May 24, 2018VAIDrug Quality Assurance2018
Aug 26, 2017NAIDrug Quality Assurance2017
Feb 26, 2016VAIDrug Quality AssuranceYes2016
Jul 24, 2015VAIDrug Quality Assurance2015
Oct 25, 2013NAIDrug Quality Assurance2014

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

Matched compliance actions

Jul 11, 2025Warning 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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