Manufacturer record
SAI Parenterals Limited: regulatory record
Last checked 3 November 2026. Source: CDSCO monthly NSQ alerts and state drug-testing laboratories
22 batches manufactured by SAI Parenterals Limited (Telangana) were declared Not of Standard Quality between April 2019 and November 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: 24RS14, Iron Sucrose Injection USP 100mg/5ml (exp Nov 2026). CDL, Kolkata (CDSCO lab) found it not of standard quality: The sample does not conform to U.S.P with respect to test for pH and Alkalinity. Listed in the November 2025 alert.
Records by type
22 records linked to SAI Parenterals Limited 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 Always check the linked government document for the current position, and tell us if something is out of date.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 |
|---|---|---|---|---|
| Iron Sucrose Injection USP 100mg/5ml | Batch 24RS14Mfg Dec 2024 · Exp Nov 2026 | The sample does not conform to U.S.P with respect to test for pH and AlkalinitypH | CDL, KolkataCDSCO lab | Nov 2025 |
| Iron Sucrose Injection USP 100 mg | Batch 24RS15Mfg Dec 2024 · Exp Nov 2026 | sample does not conform to U.S.P. with respect to the Test for "Content of chloride" "pH", and "Alkalinity".pH | CDL, KolkataCDSCO lab | Sep 2025 |
| Amikacin Sulphate Injection IP 500mg/2ml | Batch 24AM19Mfg Dec 2024 · Exp Nov 2026 | "Particulate Matter", "Bacterial Endotoxin", "Sterility" and is also not of standard quality for the reason stated under "Description".Description | CDL, KolkataCDSCO lab | Jul 2025 |
| Iron Sucrose Injection USP 100mg/5ml | Batch 24RS15Mfg Dec 2024 · Exp Nov 2026 | pH and AlkalinitypH | CDL KolkataCDSCO lab | Apr 2025 |
| Iron Sucrose Injection USP 100mg/5ml | Batch 24RS03Mfg Jan 2024 · Exp Dec 2025 | pHpH | CDL KolkataCDSCO lab | Apr 2025 |
| Iron Sucrose Injection USP 100 mg/5ml | Batch 24RS06Mfg Feb 2024 · Exp Jan 2026 | pH and AlkalinitypH | CDL KolkataCDSCO lab | Apr 2025 |
| Amikacin Sulphate Injection I.P. 500 mg | Batch 24AM18Mfg Oct 2024 · Exp Sep 2026 | Particulate matter and DescriptionDescription | CDL KolkataCDSCO lab | Apr 2025 |
| Iron Sucrose Injection USP 100 mg/5ml | Batch 24RS13Mfg Oct 2024 · Exp Sep 2026 | Alkalinity and pHpH | CDL, KolkataCDSCO lab | Mar 2025 |
| Iron Sucrose Injection USP 100 mg/ 5 ml | Batch 23IS10Mfg Dec 2023 · Exp Nov 2025 | "pH", "Alkalinity" and "Particulate Matter In Injection"Particulate matter | CDTL MumbaiCDSCO lab | Feb 2025 |
| Iron Sucrose Injection USP 100mg/5ml | Batch 24RS04Mfg Jan 2024 · Exp Dec 2025 | pHpH | CDL KolkataCDSCO lab | Jan 2025 |
| Iron Sucrose Injection USP 100mg/5ml | Batch 24RS08Mfg Feb 2024 · Exp Jan 2026 | pHpH | CDL KolkataCDSCO lab | Jan 2025 |
| Amoxycillin and Potassium Clavulanate for Injection IP 1.2 gm | Batch 23AP10Mfg Oct 2023 · Exp Sep 2025 | Particulate matter & Clarity of SolutionParticulate matter | CDL KolkataCDSCO lab | Oct 2024 |
| Ceftriaxone Sodium for Injection IP 1gm / 10 ml | Batch S24015Mfg Feb 2024 · Exp Jan 2026 | Clarity of solution, Particulate Matter & Appearance of solutionParticulate matter | CDL KolkataCDSCO lab | Jul 2024 |
| Amoxycillin & Potassium Clavulanate Injection IP 1.2 gm | Batch 23AP04Mfg May 2023 · Exp Apr 2025 | Clarity of Solution and Assay of Potassium ClavulanateAssay | CDL KolkataCDSCO lab | Jun 2024 |
| Amoxycillin&Potas sium Clavulanate InjectionIP1.2gm | Batch 23AP04Mfg May 2023 · Exp Apr 2025 | The sample does not conforms to claim as per I.P. 2022 in respect to the Test of Clarity of solution and Assay of Potassium Clavulanate calculated as Clavulanic AcidAssay | CDL KolkataCDSCO lab | May 2024 |
| Heparin Sodium Injection IP 25000 IU/5ml | Batch 22HE16Mfg Oct 2022 · Exp Sep 2024 | Description, Extractable Volume, Particulate Matter and AssayAssay | CDL KolkataCDSCO lab | Feb 2024 |
| Amikacin Sulphate Injection IP | Batch 23AM01Mfg Mar 2023 · Exp Feb 2025 | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Sep 2023 |
| Methylprednisolone Sodium Succinate for Injection USP 40mg | Batch 22MS03Mfg Nov 2023 · Exp Oct 2024 | Uniformity of Dosage Units, Loss on Drying & Assay of Methylprednisolone Sodium SuccinateAssay | CDL KolkataCDSCO lab | Aug 2023 |
| Heparin Injection I.P. 25000 IU / 5ml | Batch 22HE17Mfg Oct 2022 · Exp Sep 2024 | AssayAssay | CDL KolkataCDSCO lab | May 2023 |
| Renox-40 (Enoxaparin Sodium Injection I.P. 40 mg / 0.4ml) | Batch 21EN22Mfg Jun 2021 · Exp May 2023 | Identification & AssayAssay | CDL KolkataCDSCO lab | Feb 2023 |
| Amikacin Injection IP | Batch 21 AM02Mfg Mar 2021 · Exp Feb 2023 | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Dec 2022 |
| Gentamicin Injection I.P. 80 mg / 2ml | Batch 1794Mfg Dec 2017 · Exp Nov 2020 | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Apr 2019 |
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