Alkem Laboratories Ltd

6 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• UNAPPROVED5 refused lines

  Unapproved new drug

  The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

• NOT LISTED1 refused line

  Product not listed with FDA

  The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.

Questions about Alkem Laboratories Ltd

Is Alkem Laboratories Ltd on an FDA import alert?

Yes. As of October 26, 2026, Alkem Laboratories Ltd is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for dabur chyawanprash (jeevanprash); FDA published the listing on November 16, 2011.

Has FDA refused shipments from Alkem Laboratories Ltd?

Yes. FDA refused 5 shipment lines from Alkem Laboratories Ltd between December 5, 2025 and October 2, 2026. The most recent, on October 2, 2026, was folic acid (vitamin), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Alkem Laboratories Ltd's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 5 lines) and NOT LISTED (product not listed with fda, 1 line).

What is Alkem Laboratories Ltd's FEI number?

Alkem Laboratories Ltd's FDA Establishment Identifier (FEI) is 3006585372.

Can shipments from Alkem Laboratories Ltd still enter the U.S.?

Shipments of dabur chyawanprash (jeevanprash) from Alkem Laboratories Ltd can be detained without physical examination under Import Alert 45-02; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).