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Facility profile

Alkem Laboratories Limited

Testing & analysis · Drug product manufacturing · Dadra & Nagar Haveli and Daman & Diu 396210 · India

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed4 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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Due diligence

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
No action indicated (NAI)

Aug 30, 2019 · No conditions warranted FDA action in this inspection.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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Shows

Registration status and a latest matched no action indicated inspection.

Doesn’t show

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

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Method and source details
View full inspection and compliance history6 inspection records

FDA inspection history

6 records, Dec 2011 – Aug 2019 · 2 NAI · 4 VAI · 0 OAI

DateClassProject areaCitationsFY
Aug 30, 2019NAIDrug Quality Assurance2019
Jan 18, 2019NAIDrug Quality Assurance2019
Mar 27, 2018VAIDrug Quality AssuranceYes2018
Sep 29, 2016VAIDrug Quality Assurance2016
Oct 25, 2013VAIDrug Quality Assurance2014
Dec 9, 2011VAIDrug Quality Assurance2012

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

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

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

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