Manufacturer record

Hygeia Pharmaceuticals MFG (P) Ltd: regulatory record

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

2 batches manufactured by Hygeia Pharmaceuticals MFG (P) Ltd 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: DML 062, Montelukast and Levocetirizine Tablet (Dumont-L) (exp Nov 2027). CDL, Kolkata (CDSCO lab) found it not of standard quality: Dissolution of Levocetirizine Hydrochloride and Montelukast. Listed in the March 2025 alert.

Records by type

2 records linked to Hygeia Pharmaceuticals MFG (P) 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
2Failed 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

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 Always check the linked government document for the current position, and tell us if something is out of date.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

2
NSQ batches since 2024
2
Products affected
Assay
Most common failure
Mar 2025
Latest alert

Flagged batches per year

2024 · 12025 · 1

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Montelukast and Levocetirizine Tablet (Dumont-L) Batch DML 062Mfg Dec 2024 · Exp Nov 2027 Dissolution of Levocetirizine Hydrochloride and MontelukastDissolution CDL, KolkataCDSCO lab Mar 2025
Ambroxol,Guaiphenes in & Terbutaline Syrup (Bromex Expectorant) Batch BXE064Mfg Sep 2023 · Exp May 2026 Assay of Ambroxol Hydrochloride and Terbutaline SulphateAssay CDL KolkataCDSCO lab Feb 2024

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