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Facility profile

Apotex Pharmachem India Pvt. Ltd.

Testing & analysis · Active pharmaceutical ingredient (API) manufacturing · Karnataka 560 099 · India

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
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Listed operations

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

AnalysisActive pharmaceutical ingredient (API) manufacture
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
Voluntary action indicated (VAI)

Mar 14, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
Past action on file · 2014

More than five years old · review later records.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

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Method and source details
View full inspection and compliance history7 inspection records

FDA inspection history

7 records, Dec 2010 – Mar 2025 · 1 NAI · 5 VAI · 1 OAI

DateClassProject areaCitationsFY
Mar 14, 2025VAIDrug Quality Assurance2025
Sep 2, 2022NAIBioresearch Monitoring2022
Jan 31, 2020VAIDrug Quality Assurance2020
Jun 26, 2018VAIDrug Quality Assurance2018
Jun 3, 2016VAIDrug Quality Assurance2016
Jan 31, 2014OAIDrug Quality Assurance2014
Dec 1, 2010VAIDrug Quality Assurance2011

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

Matched compliance actions

Jun 16, 2014Warning 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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