Hamdard Laboratories India

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

Refusal charges, in plain English

• UNAPPROVED9 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.

• FRNMFGREG2 refused lines

  FRNMFGREG

• NOT LISTED2 refused lines

  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 Hamdard Laboratories India

Is Hamdard Laboratories India on an FDA import alert?

Yes. As of October 26, 2026, Hamdard Laboratories India is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for noncarbonated soft drink, n.e.c., commercially sterile; FDA published the listing on September 18, 2009.

Has FDA refused shipments from Hamdard Laboratories India?

Yes. FDA refused 9 shipment lines from Hamdard Laboratories India between June 17, 2024 and February 17, 2026. The most recent, on February 17, 2026, was multiple vitamins (mvi-12 vitamin combo) (vitamin), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Hamdard Laboratories India's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 9 lines) and FRNMFGREG (frnmfgreg, 2 lines).

What is Hamdard Laboratories India's FEI number?

Hamdard Laboratories India's FDA Establishment Identifier (FEI) is 3018147750.

Can shipments from Hamdard Laboratories India still enter the U.S.?

Shipments of noncarbonated soft drink, n.e.c., commercially sterile from Hamdard Laboratories India 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).