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Intas Pharmaceuticals Ltd

FDA import alert and refusal historyAhmedabad, IndiaFEI 3013713294

Recorded by FDA as INTAS PHARMACEUTICALS LTD

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Example subjectIntas Pharmaceuticals Lt added to Import Alert 16-129 (red list)

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As of October 26, 2026, Intas Pharmaceuticals Ltd is not on any FDA import alert in SupplierRadar's records; FDA refused 1 of its shipment line on October 2, 2026, most often for unapproved new drug (UNAPPROVED).

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
Not listed
Last import refusal
Vitamin d2 (calciferol) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Intas Pharmaceuticals Ltd

1 record, newest first. Each line links to the FDA page it came from.

2026

  1. Import refusal
    Refused, Vitamin d2 (calciferol)UNAPPROVEDEntry AEK-0710428-3
    Source

Refusal charges, in plain English

  • UNAPPROVED1 refused line

    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.

Questions about Intas Pharmaceuticals Ltd

Is Intas Pharmaceuticals Ltd on an FDA import alert?
No listing for Intas Pharmaceuticals Ltd appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the India page.
Has FDA refused shipments from Intas Pharmaceuticals Ltd?
Yes. FDA refused 1 shipment line from Intas Pharmaceuticals Ltd on October 2, 2026. The most recent, on October 2, 2026, was vitamin d2 (calciferol), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Intas Pharmaceuticals Ltd's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 1 line).
What is Intas Pharmaceuticals Ltd's FEI number?
Intas Pharmaceuticals Ltd's FDA Establishment Identifier (FEI) is 3013713294.

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Example subjectIntas Pharmaceuticals Lt added to Import Alert 16-129 (red list)

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.