Ondansetron Injection Manufacturer in India

Product Details

Ondansetron Injection — manufactured at 9M India

Product Specifications

Generic Name: Ondansetron Hydrochloride
Strength: 2mg/mL (4mg/2mL · 8mg/4mL)
Dosage Form: Solution for Injection
Route: Intravenous (IV) · Intramuscular (IM)
Container: Type I glass ampoule — 2mL (4mg) · 4mL (8mg) · Vial — 4mL (8mg)
Closure: Heat-sealed ampoule / Rubber stopper + crimp (vial)
Storage: Store below 30°C · Protect from light
Shelf Life: 24 months
Manufacturing: WHO-GMP certified sterile cleanroom · Grade A/B aseptic fill-finish
Regulatory Status: DCGI approved · Manufacturing licence held
Available For: Contract manufacturing · Third-party manufacturing · Direct supply

Ondansetron is the most widely used 5-HT3 antagonist anti-emetic globally — indicated for prevention and treatment of chemotherapy-induced, radiotherapy-induced and post-operative nausea and vomiting (PONV). It is on the WHO Essential Medicines List and is a standard formulary item in oncology units, surgical theatres, emergency departments and general wards worldwide. Among the highest-volume injectable anti-emetics in institutional procurement.

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Manufacturing & Compliance

How Ondansetron Injection is manufactured at 9M India

Sterile cleanroom manufacture

Ondansetron HCl solution prepared at 2mg/mL in Water for Injection with pH adjustment to 3.3–4.0 for chemical stability. Sterile-filtered through 0.22 micron membrane and aseptically filled into Type I glass ampoules and vials under Grade A laminar airflow in classified cleanroom. Both ampoule and vial formats are validated at our facility.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (<0.25 EU/mL) · pH (3.3–4.0) · Assay by HPLC (95.0–105.0%) · Related substances · Visible particulate matter · Colour and clarity — all in-house. COA per batch.
Documentation available within 24 hours

DCGI manufacturing licence · WHO-GMP Certificate · Certificate of Analysis · Certificate of Conformance · Stability data (real-time and accelerated, ICH-aligned) · Batch manufacturing record summary — pre-prepared and available within 24 hours for tender submission, export registration or CDMO due diligence.