Contains:- Active Ingredient：Ondansetron
– Content Specification：4mg per 2mL single dose
– Pharmaceutical Form：Sterile clear injection solution
– Applicable Standard：International pharmacopoeia specification, hospital clinical grade
– Storage Condition：Sealed storage, protected from light and high temperature
– Product Features：Precise fixed-dose packaging, convenient clinical administration, stable efficacy, suitable for large-scale hospital reserve and clinical batch use Each ampoule contain Ondansetron 4mg
– Package: 2ml ampoule *10/ box
Package:
Product Description
- Product Name：Ondansetron Injection
- Specification：4mg/2mL
- Therapeutic Category：Antiemetic Drugs / 5-HT3 Receptor Antagonists
- Core Product Positioning：High-selective antiemetic for clinical routine and emergency use
- Indicated For：Prevention and treatment of nausea and vomiting induced by chemotherapy, radiotherapy and surgery
- Usage Scenario：Oncology department, operating room, radiotherapy department, general ward and emergency department of hospitals
- Applicable Clients：Global medical institutions, hospital procurement centers, pharmaceutical wholesalers and medical supply agencies
Product Overview
Ondansetron Injection 4mg/2mL is a highly selective 5-HT3 receptor antagonist widely used in modern clinical medicine. It effectively blocks serotonin-induced vomiting reflex, providing stable and reliable antiemetic effects with high safety and low side effect incidence.
Ondansetron Injection 4mg/2mL: What the Published Guidance Says
Acid-suppression and antiemetic agents supplied as injectables and orals, including the proton-pump inhibitor and the two antiemetics carried on the WHO Model List.
Ondansetron Injection 4mg/2mL is specified against its own monograph, pack size and market registration, so the guidance below is worth reading together with the GI & Antiemetics range overview.
- The antiemetics and their age limits Section 17.2 carries metoclopramide injection 5 mg/mL in 2 mL ampoule and 10 mg tablets, with a Model List note that it is not for use in neonates. Ondansetron is listed as injection 2 mg base/mL in 2 mL ampoule, oral liquid 4 mg base/5 mL, and solid oral forms equivalent to 4, 8 and 24 mg base, indicated above one month of age. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- Omeprazole is the listed proton-pump inhibitor Section 17.1 of the Model List carries omeprazole as powder for injection 40 mg in vial, powder for oral liquid, and solid oral dosage forms of 10, 20 and 40 mg, for gastro-oesophageal reflux disease. It was first added in 2009. Therapeutic alternatives are the A02BC proton-pump inhibitor subgroup, excluding combinations. The 2025 revision replaced the 20 mg and 40 mg oral-liquid sachets with 1 mg/mL and 4 mg/mL powders for oral liquid. WHO eEML — Omeprazole
- A note on ranitidine Ranitidine appears in section 17.1 of the Model List as an antiulcer medicine, with injection, oral liquid and 150 mg tablet presentations. Since 2020 it has been subject to market-level regulatory action in several countries relating to nitrosamine (NDMA) impurities. Confirm current local registration and monograph status before ordering. WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
We quote these sources rather than paraphrase them loosely, because the detail matters commercially for Ondansetron Injection 4mg/2mL. Where your national list differs from the WHO listing, the national list governs what may be supplied and promoted locally.
Supply & Specification Data for Ondansetron Injection 4mg/2mL
| Therapeutic group | GI & Antiemetics — GI & Antiemetics |
| Manufacturer | Sinophare Bio-technology Co., Ltd. (GMP, China) |
| Documentation supplied | COA, HPLC/GC data, stability data, dossier package |
The same therapeutic range is supplied in several presentations, so one purchase order can cover a mixed requirement: Cimetidine Injection 2mL:400mg Ampoule, Omeprazole Powder for Injection 40mg, Metoclopramide Injection 10mg/2mL, Omeprazole 20mg Capsules, Ranitidine 150mg Capsules.
Testing, Monographs & Batch Documentation
Products are manufactured and tested against USP, EP, BP and CP monographs, with incoming raw-material inspection, in-process monitoring and full finished-product testing.
Every batch of Ondansetron Injection 4mg/2mL is tested to the monograph stated on the purchase order. Where a monograph is silent on the presentation, we agree a written specification with you in advance and reference it on the certificate of analysis.
Standardised GMP production workshops with an independent R&D laboratory and a complete quality-inspection centre.
The batch record for this product normally includes:
- Testing for water content and pH where applicable
- Testing for sterility and bacterial endotoxins (parenterals and ophthalmics)
- Testing for microbial limits and preservative efficacy (multi-dose presentations)
- Testing for heavy metals and elemental impurities
- Testing for packaging integrity and seal testing
- Testing for description and identification
COA, HPLC and GC data, DMF and dossier packages, plus registration support documents for national marketing-authorisation filings.
Pack Configuration, Artwork & Shipping Documents
- Shelf life: 36 months (unopened). Stability data for the marketed pack is included in the dossier.
- Labelling: we typeset the carton and leaflet in English, Arabic, French, Russian and Spanish and in any further language your market requires, carrying your own brand where the local rules allow.
- Export: commercial invoice, packing list, certificate of origin, GMP certificate, COA and the free-sale certificate issued by the country of manufacture whenever your customs or regulator asks for it.
Dossier, Authority Filings & Tender Documentation
Documents for Ondansetron Injection 4mg/2mL are issued by Sinophare Bio-technology Co., Ltd. — DML Number Jin20160068 (medicines) and Jin20160069 (paracetamol API).. Keeping one legal manufacturer across the COA, the GMP certificate and the registration file avoids assessment queries later.
- Artwork and mock-up approval pack, showing the carton, label and leaflet exactly as they will be printed for your market.
- Batch manufacturing and packaging records released for inspection on request during supplier audits.
- Re-test or renewal support when the marketing authorisation comes up for variation or renewal.
- CTD dossier modules 1–5 in editable and PDF form, with the finished-product and API sections cross-referenced.
- Site Master File and GMP certificate for the manufacturing workshops.
The context for Ondansetron Injection 4mg/2mL is its place among gastrointestinal and antiemetic medicines named in the WHO Model List. Listing status informs how programmes specify a product; it is not a substitute for the import licence or marketing authorisation of the destination country.
Buyer Questions about Ondansetron Injection 4mg/2mL
How is Ondansetron Injection 4mg/2mL packaged?
Injection presentations are quoted to your pack specification, with the artwork, pack size and labelling language confirmed before manufacture.
What documentation comes with a shipment of Ondansetron Injection 4mg/2mL?
Shipments are accompanied by a certificate of analysis covering identification, assay and related substances, together with the marketed-pack stability data and the manufacturing site GMP certificate. Shelf life: 36 months.
Does the batch documentation for Ondansetron Injection 4mg/2mL support a registration filing?
Shipments are accompanied by a certificate of analysis covering identification, assay and related substances, together with the marketed-pack stability data and the manufacturing site GMP certificate. Shelf life: 36 months. The full CTD dossier and the authority assessment file are supplied as part of a registration order; routine shipments carry the COA and stability data only.
Do you supply both ondansetron and metoclopramide?
Yes, as injectables and in oral form. Note the Model List age limits: metoclopramide is not for neonates, and ondansetron is listed above one month of age.
Can you supply ranitidine?
We can supply ranitidine where it is currently registered in the destination market. Several regulators have restricted it since 2020 over nitrosamine impurities, so confirm local status first.
Other GI & Antiemetics Products in This Range
- Cimetidine Injection 2mL:400mg Ampoule — 400mg/2mL
- Omeprazole Powder for Injection 40mg — 40mg
- Metoclopramide Injection 10mg/2mL — 10mg/2mL
- Omeprazole 20mg Capsules — 20mg
- Ranitidine 150mg Capsules — 150mg
Browse the full GI & Antiemetics range; all Injectables; the complete product catalogue.
Request a Quotation for Ondansetron Injection 4mg/2mL
For tenders and programme supply, send the line item, pack size, quantity and destination for Ondansetron Injection 4mg/2mL 4mg/2mL. We return a quotation with lead time, documentation list and sample availability in one response.
Sources & Regulatory Notes
- WHO Model List of Essential Medicines, 24th List (2025) — report of the 25th WHO Expert Committee (TRS 1064)
- WHO eEML — Omeprazole
Reference information only. The published guidance summarised on this page is quoted for professional and regulatory-context purposes and does not constitute medical advice, a prescribing recommendation or a promotion of any product for a particular indication. Prescribing decisions must follow the approved product information and national treatment guidelines in the market of use.
