Drug establishmentActive, Registered FY2026FDA warning letter on file

Apotex Research Private Limited

Apotex Research Private Limited is an FDA-registered drug establishment (FEI 3007078919) located in . The facility is active, registered for FY2026. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Oct 31, 2025
CGMP/Finished Pharmaceuticals/Adulterated

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (1)

May 29, 2015 Class II
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3007078919
Address
Bioequivalence Center, ,
Establishment type
Drug establishment
Products / operations
ANALYSIS
Registration status
Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file
None on file
Form 483 observations
None on file

FDA publishes only a subset of inspection records and Form 483s, so "None on file" is not a guarantee of a clean inspection history.

Questions

Is Apotex Research Private Limited registered with the FDA?

Yes. Apotex Research Private Limited is an FDA-registered drug establishment (FEI 3007078919) in . Its current registration status is Active, Registered FY2026.

Has Apotex Research Private Limited received an FDA warning letter?

Yes. FDA issued a warning letter to Apotex Research Private Limited; the most recent is dated Oct 31, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Apotex Research Private Limited do?

Apotex Research Private Limited's FDA-registered operations are: ANALYSIS.

Related facilities

Source: FDA public data · status as of 2026-06-01

The Quality Brief

Every new FDA drug and device warning letter and recall, summarized once a week. Free.