Drug establishmentActive, Registered FY2026FDA warning letter on file

Apotex Pharmachem India Pvt. Ltd.

Apotex Pharmachem India Pvt. Ltd. is an FDA-registered drug establishment (FEI 3005466325) 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

Find this letter on FDA.gov ›

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.

Establishment record

FEI Number

3005466325

Address

Plot No. 1a, ,

Establishment type

Drug establishment

Products / operations

ANALYSIS; API MANUFACTURE

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 Pharmachem India Pvt. Ltd. registered with the FDA?

Yes. Apotex Pharmachem India Pvt. Ltd. is an FDA-registered drug establishment (FEI 3005466325) in . Its current registration status is Active, Registered FY2026.

Has Apotex Pharmachem India Pvt. Ltd. received an FDA warning letter?

Yes. FDA issued a warning letter to Apotex Pharmachem India Pvt. Ltd.; the most recent is dated Oct 31, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Apotex Pharmachem India Pvt. Ltd. do?

Apotex Pharmachem India Pvt. Ltd.'s FDA-registered operations are: ANALYSIS; API MANUFACTURE.

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