Manufacturer record
Spen Formulations Pvt. Ltd: regulatory record
Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories
14 batches manufactured by Spen Formulations Pvt. Ltd were declared Not of Standard Quality between February 2024 and July 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: TSF-C2763, Clopidogrel & Aspirin Tablets (exp Sep 2026). Drugs Testing Laboratory, Chennai-06 (state lab) found it not of standard quality: Description. Listed in the July 2026 alert.
Records by type
14 records linked to Spen 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.
CDSCO drug alerts: Not of Standard Quality and spurious drugs
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 Always check the linked government document for the current position, and tell us if something is out of date.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.
Flagged batches per year
All flagged batches
| Product | Batch | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|
| Clopidogrel & Aspirin Tablets | Batch TSF-C2763Mfg Oct 2024 · Exp Sep 2026 | DescriptionDescription | Drugs Testing Laboratory, Chennai-06State lab | Jul 2026 |
| Gabapentin Tablets IP 300 mg | Batch TSF-DO897Mfg May 2025 · Exp Apr 2027 | The sample does not conform to IP 2022 requirements w.r.t Dissolution TestDissolution | DTL,Dalgate Srinagar kashmirState lab | May 2026 |
| Tacrolimus Capsule I.P. 2 mg | Batch CSF-D0134Mfg Jul 2025 · Exp Jun 2027 | The sample does not conform to I.P. with respect to the tests of Dissolution and Assay of TacrolimusAssay | CDL, KolkataCDSCO lab | Mar 2026 |
| Tacrolimus Capsule I.P. 1 mg | Batch CSF-D0133Mfg Jul 2025 · Exp Jun 2027 | The sample does not conform to I.P. with respect to the test of Dissolution and Assay of TacrolimusAssay | CDL, KolkataCDSCO lab | Mar 2026 |
| Tacrolimus Capsule I.P. 0.5 mg | Batch CSF-D0023Mfg Feb 2025 · Exp Jan 2027 | The sample does not conform to I.P. with respect to the tests of Dissolution and Assay of TacrolimusAssay | CDL, KolkataCDSCO lab | Mar 2026 |
| Flupentioxol & Melitracen Tablets (Flupen-Clam) | Batch TSF-D0651Mfg Mar 2025 · Exp Feb 2027 | The sample does not conform to the claim with respect to Assay of Flupentixol.Assay | DTL, JaipurState lab | Oct 2025 |
| TRIMESOL MR 35 Tablets Trimetazidine Hydrochloride Modified Release Tablets | Batch TSF-C2721AMfg Oct 2024 · Exp Sep 2026 | sample does not conforms to Manufacturer's specification with respect to the test for "Dissolution".Dissolution | CDTL, MumbaiCDSCO lab | Sep 2025 |
| Itraconazole Ofloxacin, Ornidazole & Clobetasol Propionate Cream (Fondastop C Cream) | Batch 0-102Mfg Sep 2023 · Exp Aug 2025 | The sample does not give High Performance Liquid Chromatographic and Thin Layer Chromatographic identification Test for the presence of itraconazole and Clobetasol Propionate.Identification | A.S Kambli Palghar-Zone-1 FDA, Lab MumbaiState lab | May 2025 |
| Diclofenac Sodium and Paracetamol Tablets?. (DICLOZEG-P) | Batch TSF-B5792Mfg Oct 2023 · Exp Sep 2025 | The Product is official in I.P 2022 but the same is not mentioned anywhere on the label.Labelling | State Drugs Laboratory, PunjabState lab | May 2025 |
| Fluconazole Tablets I.P. 150 mg (Megmazole- 150 Tablets) | Batch TSF-C0116Mfg Jan 2024 · Exp Dec 2025 | Assay/Content of FluconazoleAssay | RDTL GuwahatiCDSCO lab | Apr 2025 |
| Xorcid-O Suspension | Batch LSF- B0656Mfg Jul 2023 · Exp Jun 2025 | Under Investigation / The sample is found spurious as the Assay contents of Sucralfate and Oxetacaine are found to be NIL and also fails in the test for DescriptionAssay | DTL Srinagar (J&K) & MDTL Kathua (J&K)State lab | Feb 2025 |
| Bisopol-5 [BisoprololFumar ate Tablets 5 mg] | Batch TSF-C0427Mfg Feb 2024 · Exp Jan 2026 | The sample does not conform to USP standard for descriptive part of tabletsOther | DTL ThiruvananthapuramState lab | Nov 2024 |
| Levocetirizine Hydrochloride & Montelukast Sodium IP Tablets (Raremont- LC) | Batch TSF-B1689Mfg Apr 2023 · Exp Mar 2025 | Dissolution and Assay of MontelukastAssay | RDTL GuwahatiState lab | Feb 2024 |
| Chlorpheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride Syrup (Expotus-D Syrup) | Batch LSF-B0075Mfg Apr 2023 · Exp Mar 2025 | Assay of Chlorpheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideAssay | RDTL ChandigarhCDSCO 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.