Apex Laboratories Private Ltd
FDA import alert and refusal historyAlathur, IndiaFEI 3011361515
As of October 25, 2026, Apex Laboratories Private Ltd is not on any FDA import alert in SupplierRadar's records; FDA refused 3 of its shipment lines between November 13, 2025 and May 4, 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 Apex Laboratories Private Ltd
3 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalRefused, Vitamin d2 (calciferol)UNAPPROVEDEntry AEK-0349073-6Source
2025
- Import refusalRefused, Vitamin b2 (riboflavin)UNAPPROVEDEntry AEK-7952222-1Source
- Import refusalRefused, Zinc (mineral)UNAPPROVEDEntry AEK-7904000-0Source
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.
Questions about Apex Laboratories Private Ltd
- Is Apex Laboratories Private Ltd on an FDA import alert?
- No listing for Apex Laboratories Private 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 Apex Laboratories Private Ltd?
- Yes. FDA refused 3 shipment lines from Apex Laboratories Private Ltd between November 13, 2025 and May 4, 2026. The most recent, on May 4, 2026, was vitamin d2 (calciferol), charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Apex Laboratories Private Ltd's shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 3 lines).
- What is Apex Laboratories Private Ltd's FEI number?
- Apex Laboratories Private Ltd's FDA Establishment Identifier (FEI) is 3011361515.
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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.