Manufacturer record

Apex Formulations Pvt. Ltd: regulatory record

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

4 batches manufactured by Apex Formulations Pvt. Ltd (Gujarat) were declared Not of Standard Quality between February 2024 and March 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: AFL-121, Lactulose Solution U.S.P. (Apelact), 200 ml (exp Jul 2026). CDTL-Mumbai (CDSCO lab) found it not of standard quality: "Organic impurities" and. Listed in the March 2025 alert.

Records by type

4 records linked to Apex Formulations Pvt. Ltd 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
4Failed 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, Feb 2024 to Mar 2025

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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 Always check the linked government document for the current position, and tell us if something is out of date.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.

4
NSQ batches since 2024
4
Products affected
Dissolution
Most common failure
Mar 2025
Latest alert

Flagged batches per year

2024 · 12025 · 3

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Lactulose Solution U.S.P. (Apelact), 200 ml Batch AFL-121Mfg Aug 2024 · Exp Jul 2026 "Organic impurities" andOther CDTL-MumbaiCDSCO lab Mar 2025
Itraconazole Capsules (Trax - 200) Batch AFC - 102Mfg May 2024 · Exp Apr 2026 DissolutionDissolution CDTL MumbaiCDSCO lab Jan 2025
Enteric Coated Rabeprazole Sodium And Domperidone Sustained Release Capsules (Dorab SR Capsules) Batch AFC - 111Mfg Aug 2024 · Exp Jul 2026 Dissolution for DomperidoneDissolution CDTL MumbaiCDSCO lab Jan 2025
Trihexyphenidyl Hydrochloride Tablets IP 2 mg (Ridyl) Batch AR-132Mfg Jun 2023 · Exp May 2025 AssayAssay CDL KolkataCDSCO lab Feb 2024

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