Ondansetron, Indian WHO-GMP supply for chemotherapy, radiotherapy and post-operative nausea and vomiting.
A selective 5-HT3 receptor antagonist antiemetic and a WHO Essential Medicine, ondansetron is a core supportive-care agent in oncology and a workhorse of the hospital and anaesthesia formulary. 4mg and 8mg tablets, orally disintegrating tablets, 4mg/5ml oral solution, the 24mg single-day tablet, and 2mg/ml injection, from Indian WHO-GMP facilities with a product-specific CoPP and CTD dossier on file.
Multiple WHO-GMP partner lines · 4mg / 8mg tablets and ODT, 24mg tablet, oral solution, 2mg/ml injection · WHO Essential Medicine · CoPP and CTD dossier on file.
Active ingredient
Ondansetron hydrochloride dihydrate, a selective 5-HT3 receptor antagonist. It blocks serotonin 5-HT3 receptors centrally (in the chemoreceptor trigger zone) and peripherally (on vagal afferent terminals in the gut), interrupting the emetic reflex triggered by serotonin from enterochromaffin cells. This receptor selectivity is what makes it a targeted antiemetic rather than a sedating one.
Strengths stocked
4mg and 8mg film-coated tablets and orally disintegrating tablets (useful where a patient cannot reliably swallow), 4mg/5ml oral solution for paediatric and difficult-to-dose patients, the 24mg tablet for single-day highly emetogenic chemotherapy, and the 2mg/ml solution for injection (2ml single-dose and 20ml multi-dose presentations) for the hospital and anaesthesia setting.
Indications
Prevention of chemotherapy-induced nausea and vomiting (highly and moderately emetogenic), radiotherapy-induced nausea and vomiting, and post-operative nausea and vomiting. A WHO Essential Medicine and a core oncology supportive-care agent. Typical adult oral dosing is 24mg before highly emetogenic chemotherapy, or 8mg twice daily for moderately emetogenic; PONV is 16mg orally before induction, or 4mg intravenously.
Storage
Tablets and ODT stored at controlled room temperature, commonly labelled store below 30C; the oral solution is explicitly protected from light, and light protection for tablets is label-dependent. Exact conditions follow the approved product label. A standard ambient dispatch lane suited to hot-climate distribution; no cold-chain required for the solid and solution oral forms.
Shelf life
Product- and label-specific, frequently around 24 months from manufacture; refer to the specific product label and CoA for the labelled shelf life. Minimum 24 months remaining at dispatch on tablets, or we do not ship it.
Pack format
Tablets and ODT in Alu-Alu or Alu-PVC blister (Alu-Alu preferred for tropical destinations); oral solution in an amber bottle with a dosing device; injection in Type-I glass ampoule or vial. Outer carton and leaflet in the destination-regulator language, carrying the QT-prolongation and serotonin-syndrome warnings and the single-16mg-IV-dose ceiling.
Oncology supportive care, hospital and anaesthesia formularies, and public-sector tender desks across the export markets.
India is our origin. We do not sell into the Indian market. Ondansetron is exported only.
Oncology supportive-care programmes
Ondansetron prophylaxis is standard alongside chemotherapy-induced nausea and vomiting (CINV) protocols, so it is procured wherever cytotoxic and targeted therapy is supplied. We quote it as a supportive-care line alongside the oncology portfolio, in tablet, ODT and injection, for cancer-centre and teaching-hospital pharmacy.
Hospital antiemetic and PONV formularies
The post-operative nausea and vomiting use makes ondansetron a fixture of the surgical, anaesthesia and day-case formulary (oral 16mg before induction, or 4mg intravenous). High-volume 2mg/ml injection and 4mg/8mg oral tenders run through hospital pharmacy committees, where the QT and stewardship documentation matters.
GCC and Middle East tender desks
Through licensed local importers against MoH formulary tenders. UAE registration is now held with the Emirates Drug Establishment (EDE) (which took over from MOHAP in December 2025); Saudi Arabia via the SFDA and NUPCO; the wider GCC via national bodies or the GCC central route. Product-specific CoPP and CTD dossier supported.
Africa and global public-sector
Public-sector hospital and cancer-programme tenders across Nigeria (NAFDAC), Kenya (KEMSA, MEDS), Ghana, South Africa (SAHPRA), Ethiopia (EFDA, EPSS), Tanzania (TMDA, MSD), Uganda (NDA, NMS) and Rwanda, plus NGO and teaching-hospital supply. Ondansetron's Essential-Medicines status supports its inclusion in national formularies and central procurement.
QT prolongation and the withdrawn 32mg IV dose, serotonin syndrome, and the pregnancy question, ondansetron is everyday but the safety margins are specific.
Typical adult oral dosing is 24mg before highly emetogenic chemotherapy, or 8mg twice daily for moderately emetogenic; PONV is 16mg orally before induction of anaesthesia, or 4mg intravenously at induction. The intravenous CINV regimen is weight-based (0.15 mg/kg over 15 minutes, repeated 4 and 8 hours after the first dose). The dose-limiting safety issue is QT prolongation. In 2012 the FDA determined that a single 32mg intravenous dose causes dose-dependent QT-interval prolongation, which carries a risk of the potentially fatal arrhythmia Torsades de Pointes; that single 32mg intravenous dose was removed from the label and withdrawn from the market, and no single intravenous dose should now exceed 16mg. This does not affect approved oral dosing, including the 24mg oral chemotherapy dose. The QT risk is greatest in patients with congenital long QT syndrome, and is increased in heart failure, bradyarrhythmias, electrolyte abnormalities (hypokalaemia, hypomagnesaemia), or with other QT-prolonging medicines; ECG and electrolyte monitoring is advised in such patients, and electrolytes should be corrected before use. Serotonin syndrome has been reported when ondansetron is combined with other serotonergic agents (SSRIs, SNRIs, MAOIs, mirtazapine, triptans), and the label carries this warning. The common adverse effects are headache and constipation, both characteristic 5-HT3-antagonist class effects, along with malaise, diarrhoea and dizziness. On pregnancy (stated carefully): ondansetron is not FDA-approved for nausea and vomiting of pregnancy, so such use is off-label, and the evidence is genuinely mixed. A large 2018 Medicaid cohort study (Huybrechts and colleagues, JAMA) found a small increased risk of oral clefts (adjusted relative risk 1.24, 95% confidence interval 1.03 to 1.48) with no increased risk of cardiac malformations (adjusted relative risk 0.99, 95% confidence interval 0.93 to 1.06); a 2020 meta-analysis (Picot and colleagues) reported small associations whose confidence intervals often reached 1.0. Any absolute increase, if real, is small, and several analyses find no significant association. Use in pregnancy is a clinical decision for a prescriber. This information is educational and is not medical advice; the prescribing decision belongs to the clinician, the clear labelling is ours.
The documentation pack a regulator actually asks for.
Ondansetron is a WHO Essential Medicine and an off-patent, high-volume commodity molecule. Our role is on the supply side: we sit between the Indian WHO-GMP facility and your clinical, regulatory or procurement team and take the paperwork off both sides. Ondansetron is not WHO-prequalified (antiemetics fall outside WHO Prequalification's priority-disease scope), so we rely on WHO-GMP, a product-specific CoPP and national registration, and we do not claim WHO-PQ.
CTD Module 3
Full chemistry, manufacturing and controls section in eCTD-ready format where the importing authority accepts it, with the Module 2 quality overall summary. Prepared across the tablet, ODT, oral-solution and injection forms.
CoA and MoA, per batch
HPLC assay, related substances per Ph.Eur./USP, uniformity of dosage units, dissolution profile, pH and, for the injection, sterility and bacterial endotoxin, signed by the manufacturer's authorised QC head. Salt stated as the hydrochloride dihydrate.
CoPP, WHO-GMP, MFG licence
A product-specific Certificate of Pharmaceutical Product in WHO format, issued per dosage form and strength by CDSCO (applications route through the ONDLS digital portal, mandatory since 15 July 2025; a CoPP is typically valid for two years), with the WHO-GMP certificate and manufacturing licence, apostilled where required.
Pack insert, labels, artwork
Destination-language PIL and labelling. The QT-prolongation warning, the single-16mg-intravenous-dose ceiling, the serotonin-syndrome caution and the QT risk-factor list are set on the insert. Artwork QC before print, not after.
Temperature and stability
Ambient dispatch; the integrity factors are moisture and, for the solution, light exclusion. For hot, humid markets we confirm Zone IVb (30C/75% RH) stability data, the WHO/ICH long-term condition for these destinations; India's own domestic long-term condition is 30C/70% RH.
Pharmacovigilance
A named PV contact organised in the destination market against registration, with Periodic Safety Update Reports to ICH E2C. QT-interval events, serotonin syndrome and hypersensitivity are the PSUR watch items.
Oncology supportive care and the hospital formulary cluster.
Ondansetron rarely travels alone: it is procured alongside the cytotoxic and targeted therapy it supports, the anaemia and growth-factor lines of supportive care, and the wider hospital formulary.
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Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength and form (4mg / 8mg tablet or ODT, 4mg/5ml solution, 24mg tablet, 2mg/ml injection), pack, volume, destination, and channel: oncology supportive-care programme, hospital or anaesthesia (PONV) formulary, or government tender. Flag if QT or antimicrobial-stewardship-style documentation is needed for the receiving formulary.
- We route to the right line. Multiple WHO-GMP ondansetron lines are on the M Care roster across the tablet, ODT, oral-solution and injection forms. We confirm the packaging suited to your climate zone and the shelf life at dispatch.
- Commercial and regulatory offer. FOB / CIF price, lead time, CoPP and CTD dossier status per destination, and the documentation pack you will receive. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Ambient dispatch with moisture and light protection, in-transit logging, on-arrival inspection.
- After delivery. Batch records, CoA and thermal logs archived for the full shelf life. Pharmacovigilance contact opened on registration; QT-interval events and serotonin syndrome are the watch items.
Ondansetron supply, the specific questions.
What strengths and forms of ondansetron do you supply?
We source the full commodity range: 4mg and 8mg film-coated tablets and orally disintegrating tablets, 4mg/5ml oral solution for paediatric and difficult-to-dose patients, the 24mg tablet for single-day highly emetogenic chemotherapy, and the 2mg/ml solution for injection in 2ml single-dose and 20ml multi-dose presentations. Tell us the form, strength and pack and we route to the matching WHO-GMP line.
Is ondansetron WHO prequalified?
No, and we will not claim it is. WHO Prequalification focuses on priority disease areas (HIV, TB, malaria, reproductive and maternal health, neglected tropical diseases), and antiemetics fall outside its current scope. For institutional and tender supply we provide WHO-GMP evidence and a product-specific CoPP, and rely on national registration rather than any WHO-PQ claim.
How do you handle the QT-prolongation and 32mg-dose safety point?
Directly, on every pack. In 2012 the FDA removed the single 32mg intravenous dose from the label after evidence of dose-dependent QT prolongation and Torsades de Pointes risk, and no single intravenous dose should now exceed 16mg. This does not affect approved oral dosing. Our labelling carries the QT-prolongation warning, the 16mg intravenous ceiling, the QT risk-factor list (congenital long QT, heart failure, electrolyte disturbance, other QT-prolonging drugs) and the serotonin-syndrome caution. ECG and electrolyte monitoring in at-risk patients is a prescribing responsibility; the clear labelling is ours.
Can you supply ondansetron for use in pregnancy?
We supply the product; the clinical decision is the prescriber's, and we present the evidence honestly rather than marketing a use. Ondansetron is not FDA-approved for nausea and vomiting of pregnancy, so such use is off-label and the evidence is mixed: a 2018 JAMA cohort found a small increased risk of oral clefts with no increased cardiac risk, while a 2020 meta-analysis reported small signals whose confidence intervals often reached 1.0. Any absolute increase, if real, is small. This is educational information, not medical advice.
Which markets and channels do you ship ondansetron into?
The UK (NHS hospital and primary-care, or MHRA Specials during shortage), the GCC (UAE via the EDE, Saudi Arabia via the SFDA and NUPCO, and Kuwait, Oman, Qatar and Bahrain) through licensed importers, and sub-Saharan Africa for public-sector and cancer-programme tenders. Oncology supportive-care and hospital PONV formularies are the main demand patterns. Germany, France, Brazil, Mexico and the Philippines through licensed importers. We do not supply into India.
Do you provide CTD dossiers and Zone IVb stability data?
Yes. Full CTD Module 3 dossiers are available against a non-disclosure agreement for the MHRA, the GCC regulators (EDE, SFDA and the GCC central route), NAFDAC, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. For hot and humid destinations we confirm Zone IVb (30C/75% relative humidity) long-term stability data and specify the packaging accordingly.
Send the specifics. You'll have a price inside one working day.
Strength and form (4mg / 8mg tablet or ODT, 4mg/5ml solution, 24mg tablet, 2mg/ml injection), pack, volume, destination, and channel: oncology supportive care, hospital or anaesthesia (PONV) formulary, or government tender, plus any QT or stewardship documentation the formulary needs. That is the enquiry. Everything else is on us.