Manufacturer record

Sun Pharma Laboratories Ltd: regulatory record

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

11 batches manufactured by Sun Pharma Laboratories Ltd (Sikkim) were declared Not of Standard Quality between February 2021 and September 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: SIH0304A, Clopidogrel and Aspirin Capsules (exp Nov 2027). FDAL, M. S Chhatrapatri Sambhajinagar, F.D.A Mahrasthra State (state lab) found it not of standard quality: The Sample does not Comply for description, as- the Capsule Containing Lumps of Multi-Coloured granules. Listed in the September 2026 alert.

Records by type

11 records linked to Sun Pharma Laboratories 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
11Failed 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 2021 to Sep 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 Always check the linked government document for the current position, and tell us if something is out of date.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.

11
NSQ batches since 2021
9
Products affected
Assay
Most common failure
Sep 2026
Latest alert

Flagged batches per year

2021 · 32022 · 22023 · 32024 · 22026 · 1

All flagged batches

Product Batch Reason declared NSQ Tested by Alert
Clopidogrel and Aspirin Capsules Batch SIH0304AMfg Feb 2026 · Exp Nov 2027 The Sample does not Comply for description, as- the Capsule Containing Lumps of Multi-Coloured granulesDescription FDAL, M. S Chhatrapatri Sambhajinagar, F.D.A Mahrasthra StateState lab Sep 2026
Rifaximin Tablets (Rifagut 400) Batch GKE0938 AMfg Jun 2023 · Exp May 2025 Not applicableOther Not applicableState lab Apr 2024
Levetiracetam Tablets IP (Levipil 500) Batch SIE1003AMfg Apr 2023 · Exp Mar 2025 DissolutionDissolution CDL KolkataCDSCO lab Jan 2024
Rosuvastatin Tablets IP (Rosuvas 10 Tablets) Batch SID3056AMfg Nov 2022 · Exp Apr 2025 Description and Assay of Rosuvastatin Calcium calculated as RosuvastatinAssay RDTL ChandigarhState lab Jul 2023
Montek LC (Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP) Batch SIC3283AMfg Dec 2021 · Exp May 2024 Identification & Assay of Montelukast Sodium & Assay of Levocetirizine HydrochlorideAssay CDL KolkataCDSCO lab Feb 2023
Pan -D (Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules IP) Batch 22442611Mfg Sep 2022 · Exp Aug 2024 Identification and AssayAssay CDL KolkataCDSCO lab Jan 2023
Montek� LC (Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP) Batch SIC1932AMfg Aug 2021 · Exp Jan 2024 Identification and Assay of MontelukastAssay RDTL GuwahatiState lab Oct 2022
Pantoprazole Gastro Resistant and Domperidone Prolonged-Release Capsules IP Batch RPB0651AMfg Jan 2021 · Exp Dec 2022 Identification and AssayAssay RDTL GuwahatiState lab Apr 2022
Rosuvas� F-5 (Rosuvastatin and Fenofibrate Tablets I.P.) Batch EMU2687Mfg Sep 2019 · Exp Feb 2022 Dissolution of FenofibrateDissolution CDL KolkataCDSCO lab May 2021
Rosuvas 20 (Rosuvastatin Tablets I.P.) Batch EMX0685Mfg Mar 2020 · Exp Aug 2023 Dissolution & AssayAssay CDL KolkataCDSCO lab May 2021
Rosuvas 20 (Rosuvastatin Tablets I.P.) Batch EMX0174Mfg Jan 2020 · Exp Jun 2022 Uniformity of Weight, Dissolution and AssayAssay CDL KolkataCDSCO lab Feb 2021

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