Emami Limited

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

Refusal charges, in plain English

• UNAPPROVED3 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.

• DIRSEXMPT1 refused line

  DIRSEXMPT

• FRNMFGREG1 refused line

  FRNMFGREG

• 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 Emami Limited

Is Emami Limited on an FDA import alert?

Yes. As of October 26, 2026, Emami Limited is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for zandu satavarex delicious chocolate flavor galactagogue; FDA published the listing on December 18, 2015.

Has FDA refused shipments from Emami Limited?

Yes. FDA refused 3 shipment lines from Emami Limited between January 11, 2023 and December 17, 2025. The most recent, on December 17, 2025, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Emami Limited's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 3 lines) and DIRSEXMPT (dirsexmpt, 1 line).

What is Emami Limited's FEI number?

Emami Limited's FDA Establishment Identifier (FEI) is 3014273187.

Can shipments from Emami Limited still enter the U.S.?

Shipments of zandu satavarex delicious chocolate flavor galactagogue from Emami Limited 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).