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Sun Pharma Drugs Pvt Ltd

FDA import alert and refusal historyNamli, IndiaFEI 3011116632

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Example subjectSun Pharma Drugs Pvt Lt added to Import Alert 16-129 (red list)

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As of October 25, 2026, Sun Pharma Drugs Pvt Ltd is not on any FDA import alert in SupplierRadar's records; FDA refused 2 of its shipment lines between September 30, 2020 and February 12, 2025, 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
Amla (herbal & botanicals ii) · UNAPPROVED
Last warning letter
None found
Last inspection
None on record

Every FDA record for Sun Pharma Drugs Pvt Ltd

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

2025

  1. Import refusal
    Refused, Amla (herbal & botanicals ii)UNAPPROVEDEntry 799-5614430-8
    Source

2020

  1. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry AEK-7860604-0
    Source

Refusal charges, in plain English

  • UNAPPROVED2 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.

Questions about Sun Pharma Drugs Pvt Ltd

Is Sun Pharma Drugs Pvt Ltd on an FDA import alert?
No listing for Sun Pharma Drugs Pvt Ltd appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the India page.
Has FDA refused shipments from Sun Pharma Drugs Pvt Ltd?
Yes. FDA refused 2 shipment lines from Sun Pharma Drugs Pvt Ltd between September 30, 2020 and February 12, 2025. The most recent, on February 12, 2025, was amla (herbal & botanicals ii), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Sun Pharma Drugs Pvt Ltd's shipments?
The most frequent charge is UNAPPROVED (unapproved new drug, 2 lines).
What is Sun Pharma Drugs Pvt Ltd's FEI number?
Sun Pharma Drugs Pvt Ltd's FDA Establishment Identifier (FEI) is 3011116632.

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Example subjectSun Pharma Drugs Pvt 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.