Manufacturer record

Spanker Biotech Ltd: regulatory record

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

2 batches manufactured by Spanker Biotech Ltd (Himachal Pradesh) were declared Not of Standard Quality between December 2025 and March 2026. 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: SPK-1412, Enteric Coated Rabeprazole Sodium & Domperidone Sustained release Capsules (exp Apr 2027). CDL, Kolkata (CDSCO lab) found it not of standard quality: The sample does not conform to Manufacturer's Specification with respect to the test of Dissolution of Rabeprazole Sodium in buffer stage. Listed in the March 2026 alert.

Records by type

2 records linked to Spanker Biotech 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, Dec 2025 to Mar 2026

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 Always check the linked government document for the current position, and tell us if something is out of date.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

2
NSQ batches since 2025
2
Products affected
Assay
Most common failure
Mar 2026
Latest alert

Flagged batches per year

2025 · 12026 · 1

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Enteric Coated Rabeprazole Sodium & Domperidone Sustained release Capsules Batch SPK-1412Mfg May 2025 · Exp Apr 2027 The sample does not conform to Manufacturer's Specification with respect to the test of Dissolution of Rabeprazole Sodium in buffer stage.Dissolution CDL, KolkataCDSCO lab Mar 2026
Enteric Coated Rabeprazole Sodium & Domperidone Sustained release Capsules Rabizole - DSR Batch SPK 1386Mfg Nov 2024 · Exp Oct 2026 The sample does not conform to Manufacturers Specification with respect to The Test of Dissolution of Rabeprazole Sodium and Assay of Rabeprazole Sodium.Assay CDL, KolkataCDSCO lab Dec 2025

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