Manufacturer record
SAI Parenterals Limited: regulatory record
Last checked 20 September 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.
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 Always check the linked government document for the current position, and tell us if something is out of date.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 | 24RS14Mfg 2024-12 · Exp 2026-11 | 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 | 24RS15Mfg 2024-12 · Exp 2026-11 | 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 | 24AM19Mfg 2024-12 · Exp 2026-11 | "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 | 24RS15Mfg 2024-12 · Exp 2026-11 | pH and AlkalinitypH | CDL KolkataCDSCO lab | Apr 2025 |
| Iron Sucrose Injection USP 100mg/5ml | 24RS03Mfg 2024-01 · Exp 2025-12 | pHpH | CDL KolkataCDSCO lab | Apr 2025 |
| Iron Sucrose Injection USP 100 mg/5ml | 24RS06Mfg 2024-02 · Exp 2026-01 | pH and AlkalinitypH | CDL KolkataCDSCO lab | Apr 2025 |
| Amikacin Sulphate Injection I.P. 500 mg | 24AM18Mfg 2024-10 · Exp 2026-09 | Particulate matter and DescriptionDescription | CDL KolkataCDSCO lab | Apr 2025 |
| Iron Sucrose Injection USP 100 mg/5ml | 24RS13Mfg 2024-10 · Exp 2026-09 | Alkalinity and pHpH | CDL, KolkataCDSCO lab | Mar 2025 |
| Iron Sucrose Injection USP 100 mg/ 5 ml | 23IS10Mfg 2023-12 · Exp 2025-11 | "pH", "Alkalinity" and "Particulate Matter In Injection"Particulate matter | CDTL MumbaiCDSCO lab | Feb 2025 |
| Iron Sucrose Injection USP 100mg/5ml | 24RS04Mfg 2024-01 · Exp 2025-12 | pHpH | CDL KolkataCDSCO lab | Jan 2025 |
| Iron Sucrose Injection USP 100mg/5ml | 24RS08Mfg 2024-02 · Exp 2026-01 | pHpH | CDL KolkataCDSCO lab | Jan 2025 |
| Amoxycillin and Potassium Clavulanate for Injection IP 1.2 gm | 23AP10Mfg 2023-10 · Exp 2025-09 | Particulate matter & Clarity of SolutionParticulate matter | CDL KolkataCDSCO lab | Oct 2024 |
| Ceftriaxone Sodium for Injection IP 1gm / 10 ml | S24015Mfg 2024-02 · Exp 2026-01 | Clarity of solution, Particulate Matter & Appearance of solutionParticulate matter | CDL KolkataCDSCO lab | Jul 2024 |
| Amoxycillin & Potassium Clavulanate Injection IP 1.2 gm | 23AP04Mfg 2023-05 · Exp 2025-04 | Clarity of Solution and Assay of Potassium ClavulanateAssay | CDL KolkataCDSCO lab | Jun 2024 |
| Amoxycillin&Potas sium Clavulanate InjectionIP1.2gm | 23AP04Mfg 2023-05 · Exp 2025-04 | 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 | 22HE16Mfg 2022-10 · Exp 2024-09 | Description, Extractable Volume, Particulate Matter and AssayAssay | CDL KolkataCDSCO lab | Feb 2024 |
| Amikacin Sulphate Injection IP | 23AM01Mfg 2023-03 · Exp 2025-02 | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Sep 2023 |
| Methylprednisolone Sodium Succinate for Injection USP 40mg | 22MS03Mfg 2023-11 · Exp 2024-10 | Uniformity of Dosage Units, Loss on Drying & Assay of Methylprednisolone Sodium SuccinateAssay | CDL KolkataCDSCO lab | Aug 2023 |
| Heparin Injection I.P. 25000 IU / 5ml | 22HE17Mfg 2022-10 · Exp 2024-09 | AssayAssay | CDL KolkataCDSCO lab | May 2023 |
| Renox-40 (Enoxaparin Sodium Injection I.P. 40 mg / 0.4ml) | 21EN22Mfg 2021-06 · Exp 2023-05 | Identification & AssayAssay | CDL KolkataCDSCO lab | Feb 2023 |
| Amikacin Injection IP | 21 AM02Mfg 2021-03 · Exp 2023-02 | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Dec 2022 |
| Gentamicin Injection I.P. 80 mg / 2ml | 1794Mfg 2017-12 · Exp 2020-11 | Description & Particulate MatterDescription | CDL KolkataCDSCO lab | Apr 2019 |
Right of reply. Manufacturers may submit a response or a laboratory re-test result; it is published unedited alongside this record. Submit a response.