Manufacturer record
Affine Formulations Ltd: regulatory record
Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories
2 batches manufactured by Affine Formulations Ltd (Himachal Pradesh) were declared Not of Standard Quality in January 2023. 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: PD2206098, Peritoneal Dialysis Solution IP with 2.5% w/v Dextrose (exp May 2024). RDTL Chandigarh (CDSCO lab) found it not of standard quality: Assay of Calcium, Magnesium and Lactate. Listed in the January 2023 alert.
Records by type
2 records linked to Affine Formulations 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 Always check the linked government document for the current position, and tell us if something is out of date.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 |
|---|---|---|---|---|
| Peritoneal Dialysis Solution IP with 2.5% w/v Dextrose | Batch PD2206098Mfg Jun 2022 · Exp May 2024 | Assay of Calcium, Magnesium and LactateAssay | RDTL ChandigarhCDSCO lab | Jan 2023 |
| Levocetirizine Hydrochloride Tablets IP (Levocetirizine Tablets) | Batch AF-22T619Mfg Aug 2022 · Exp Jul 2024 | DissolutionDissolution | RDTL ChandigarhCDSCO lab | Jan 2023 |
Right of reply. Manufacturers may submit a response or a laboratory re-test result; it is published unedited alongside this record. Submit a response.