Manufacturer record

Gufic Biosciences Ltd. National Highway No. 8: regulatory record

Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories

1 batch manufactured by Gufic Biosciences Ltd. National Highway No. 8 (Gujarat) was declared Not of Standard Quality in October 2025. Records are batch-specific findings by government laboratories as published in CDSCO's monthly alerts; where a company has stated that a flagged batch was counterfeit, that statement is noted when reported.

Most recent flagged batch: AB240590B, Liposomal Amphotericin B Injection 50 Mg (Gufisome) (exp Nov 2026). CDL, Kolkata (CDSCO lab) found it not of standard quality: The sample does not conform to Manufacturer's Specification with respect to test for pH, Free Drugs, Particulate Matter, Reconstitution. Listed in the October 2025 alert.

Records by type

1 record linked to Gufic Biosciences Ltd. National Highway No. 8 in the datasets we hold. A zero means nothing is on record in those datasets, not that nothing ever happened. What the labels mean.

0Banned or prohibited
0Recalled or suspended
1Failed a lab test
0Regulatory notice
Primary government sourceTier 1: government primary source

CDSCO drug alerts: Not of Standard Quality and spurious drugs

CDSCO · CDSCO monthly NSQ alerts, Oct 2025 to Oct 2025

View original document

Scope. A company appearing here is not a finding that its products are unsafe. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.

1
NSQ batches since 2025
1
Products affected
Assay
Most common failure
Oct 2025
Latest alert

Flagged batches per year

2025 · 1

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Liposomal Amphotericin B Injection 50 Mg (Gufisome) Batch AB240590BMfg Dec 2024 · Exp Nov 2026 The sample does not conform to Manufacturer's Specification with respect to test for pH, Free Drugs, Particulate Matter, Reconstitution Time, Clarity Of Solution and AssayAssay CDL, KolkataCDSCO lab Oct 2025

Right of reply. Manufacturers may submit a response or a laboratory re-test result; it is published unedited alongside this record. Submit a response.