Description
Ondansetron Tablet
Ondansetron Hydrochloride Tablets (4 mg / 8 mg)
Healthy Life Pharma Private Limited, alongside our specialized global export division Healthy Inc, is a leading Indian manufacturer, CDMO services provider, and wholesale exporter of advanced oncology support, critical care, and gastroenterology therapeutics. We manufacture ultra-high-purity, kinetically stable Ondansetron Hydrochloride Tablets in our WHO–GMP certified, high-precision solid dosage manufacturing facilities. This highly potent “Serotonin $5\text{-HT}_{3}$ Receptor Antagonist” acts as a major strategic product for oncology clinics, hospital intensive care networks, national health ministry tenders, and international B2B wholesale marketplaces across Europe, the CIS region, Africa, LATAM, and South-East Asia.
Product Overview
This formulation operates as a “Central & Peripheral Emetic Reflex Blocker.” It ensures patient safety by chemically decoupling the physiological triggers that transmit nausea signals from the gastrointestinal tract directly to the brain’s vomiting center.
Mechanism 1 (Peripheral Vagal Antagonism): Chemotherapy and radiation physically damage intestinal enterochromaffin cells, releasing massive amounts of serotonin. Ondansetron physically binds to and chemically blocks peripheral $5\text{-HT}_{3}$ receptors on vagal nerve afferents in the gut, stopping the initial emetic signal.
Mechanism 2 (Central Chemoreceptor Suppression): It physically crosses into central nervous structures to block $5\text{-HT}_{3}$ receptors located inside the Chemoreceptor Trigger Zone (CTZ) and the nucleus tractus solitarius in the medulla, completely neutralizing centrally driven emetic reflexes.
Mechanism 3 (Gastrointestinal Kinetic Neutrality): Unlike older antiemetics, Ondansetron operates without physically altering dopamine receptors or accelerating gastric emptying. This chemically eliminates side effects like muscle tremors or acute cramping.
Product Composition & Available Strengths
We supply this critical supportive therapeutic in standard, internationally recognized strengths designed for exact preventative and rescue dosing.
| Active Ingredient | Available Strengths | Primary Clinical Target |
| Ondansetron HCl IP / BP / USP | 4 mg | Standard Prophylaxis: For moderate emetogenic chemotherapy, general post-operative rescue, and pediatric care. |
| Ondansetron HCl IP / BP / USP | 8 mg | High-Potency Protection: For highly emetogenic cisplatin-based cancer regimens and severe surgical recovery. |
Technical & Logistics Specifications
HS Code: 3004.90.99 (Medicaments acting on the alimentary tract / Antiemetics)
CAS Number: 103639-04-9 (Ondansetron Hydrochloride)
Dosage Formats: Oral Film-Coated Tablets or Orally Disintegrating Tablets (ODT) engineered to physically melt on the tongue without water within 10 seconds.
Packaging: 10 Tablets per Blister Strip packed in high-barrier Alu-Alu (Cold-Form Foil) or thick PVC/PVDC foils. Our premium packaging configurations completely block environmental moisture and light, guaranteeing a full 36-month shelf life in Zone IVb tropical environments.
Manufacturing Authority & Compliance
Taste-Masking ODT Matrix Engineering: Because active Ondansetron is physically bitter, and vomiting patients struggle to swallow standard tablets, our processing lines feature an Advanced Micropellet Taste-Masking Matrix. This allows our Orally Disintegrating Tablets (ODTs) to dissolve instantly on the tongue with a highly palatable, non-bitter taste profile.
Micro-Dose Content Uniformity: Since Ondansetron is compressed at low active doses (4mg/8mg) relative to total tablet mass, we employ Automated Multi-Stage Geometric Solid Blending, physically guaranteeing absolute chemical content uniformity across every tablet produced.
In-Vitro Dissolution Profiling: Every production batch physically undergoes Comparative Dissolution Profiling, chemically verifying that our generic formulations precisely match the kinetic disintegration curves of global innovator benchmarks (such as Zofran).
Primary Indications
Oncology Support: Prevention of acute and delayed nausea and vomiting associated with Highly Emetogenic Cancer Chemotherapy (CINV) and Total Body Irradiation (RINV).
Surgery & Anesthesia: Prevention and treatment of Post-Operative Nausea and Vomiting (PONV) following major surgical interventions.
Emergency Medicine: Off-label management of severe, dehydration-inducing gastroenteritis in pediatric and adult emergency departments.
Usage Instructions
The Prophylactic Window: To maximize chemical efficiency, oral doses must be administered physically 30 to 60 minutes before the start of cancer chemotherapy or induction of surgical anesthesia.
ODT Administration Guide: For Orally Disintegrating Tablets, peel open the blister foil with dry hands (do not push the tablet through the foil), place it physically on top of the tongue, allow it to melt completely, and swallow with saliva. Water is not physically required.
QT-Interval Caution: In high doses, Ondansetron can chemically alter cardiac conduction. Hospital teams should monitor patients with pre-existing electrolyte imbalances or prolonged cardiac intervals physically.
Safety Warning: CRITICAL ONCOLOGY SUPPORT & ANTIEMETIC. For Medical Professional Supervision Only. QT Elongation Warning: May chemically cause dose-dependent QT Interval Prolongation; monitor cardiac rhythm physically in high-risk profiles. Constipation Note: Can physically slow colonic transit; monitor patients for severe constipation chemically. Contraindication: Absolute contraindication for co-administration with Apomorphine (profound hypotension risk). Do not use in patients presenting with a known hypersensitivity to selective 5-HT3 antagonists.
Global Export & Contract Manufacturing (CDMO Services)
Healthy Life Pharma Private Limited provides complete, fully validated Third-Party Contract Manufacturing (CDMO) and bulk private-label export pipelines for generic Ondansetron Tablets and ODTs. Whether you are expanding an oncology supportive care catalog across the CIS, bidding on a National Ministry of Health Tender in Sub-Saharan Africa, or managing an active listing on an international digital B2B Pharmaceutical Marketplace in Southeast Asia or LATAM, we deliver all required documentation (WHO-GMP Certificate, COPP, COA, Stability Matrix Records, and Complete CTD Format Dossier sets) for rapid global registration and custom clearance.
Commercial & Bulk Procurement Inquiries:
Corporate Head Office: Mumbai, Maharashtra, India
Primary Manufacturing Base: Boisar, Maharashtra, India
WhatsApp / Direct Call: +91 7710003340
Corporate Email: info@healthyinc.co.in
