Ondansetron

Ondansetron is a selective serotonin 5-HT₃ receptor antagonist, widely used for the prevention and treatment of nausea and vomiting associated with chemotherapy, radiation therapy, and post-operative recovery. Due to its fast onset of action, excellent tolerability, and high efficacy, Ondansetron has become a frontline treatment across oncology, surgery, gastroenterology, and emergency care.

At BluepillExpress, we specialize in WHO-GMP certified third-party manufacturing of Ondansetron across a variety of formulations. Our focus is on delivering high-quality, customizable, and internationally compliant pharmaceutical products to our partners worldwide—including hospitals, marketing companies, NGOs, and health ministries.

Product Overview

Generic Name: Ondansetron
Pharmacological Class: Selective Serotonin 5-HT₃ Receptor Antagonist
Therapeutic Use: Antiemetic

Available Dosage Forms and Strengths

• Tablets (Immediate Release):
  • Ondansetron 4 mg
  • Ondansetron 8 mg
• Orally Disintegrating Tablets (ODTs):
  • Ondansetron ODT 4 mg
  • Ondansetron ODT 8 mg
• Oral Solution:
  • Ondansetron 2 mg/mL
• Injectable Formulation:
  • Ondansetron Injection 2 mg/mL (in 2 mL and 4 mL ampoules)
• Syrup Formulation (Pediatric Use):
  • Ondansetron 2 mg/5 mL

Packaging Options

• Blister strips (Alu-Alu or PVC-Alu, 10×10)
• Bottled syrups with child-resistant caps
• Ampoules in boxes of 5 or 10 units
• Multilingual packaging for exports
• Private-label branding with customized artwork

Indications

Ondansetron is indicated for the prevention and treatment of:

• Chemotherapy-induced nausea and vomiting (CINV)
• Radiotherapy-induced nausea and vomiting (RINV)
• Post-operative nausea and vomiting (PONV)
• Gastroenteritis-associated emesis
• Hyperemesis gravidarum (off-label)
• Nausea associated with opioid therapy or general anesthesia

Ondansetron is commonly used in oncology, emergency departments, pediatrics, surgical recovery, and obstetric care for its potent and targeted antiemetic properties.

Mechanism of Action

Ondansetron works by blocking serotonin (5-HT₃) receptors, which are found in:

• The vagal nerve terminals of the gastrointestinal tract
• The chemoreceptor trigger zone (CTZ) in the brain

By inhibiting the action of serotonin—a key chemical mediator in nausea and vomiting—Ondansetron effectively prevents emesis triggered by chemotherapy, radiation, and other stimuli.

Unlike dopamine antagonists, it does not cause extrapyramidal side effects, making it a safer option for long-term and high-risk patients.

Pharmacokinetics

• Absorption: Rapid and complete orally; peak plasma concentration in 1.5–2 hours
• Bioavailability: ~56% (oral); 100% (IV)
• Protein Binding: ~70–76%
• Metabolism: Extensive hepatic metabolism (CYP1A2, CYP2D6, CYP3A4)
• Elimination Half-life: 3–5 hours in adults (longer in elderly or hepatic impairment)
• Excretion: Renal and fecal pathways

Due to its predictable pharmacokinetics and dose-response profile, Ondansetron is suitable for both short-term and continuous use in clinical settings.

Why Choose BluepillExpress for Ondansetron Manufacturing?

1. WHO-GMP Certified Facilities

Our facilities are certified to WHO-GMP, ISO 9001:2015, and Schedule M standards, ensuring the highest level of compliance and hygiene in production. We operate:

• Dedicated oral solid dosage manufacturing areas
• Sterile injectable zones with cleanroom classifications
• Liquid oral lines for pediatric and geriatric formulations
• Automated blister packing and ampoule filling lines

Each production unit is equipped with state-of-the-art technology to meet global demand and therapeutic consistency.

2. Formulation Expertise

BluepillExpress supports custom development of:

• Orally Disintegrating Tablets (ODT) for elderly and pediatric use
• Syrups and drops for pediatric and dysphagic patients
• High-stability injectable solutions with long shelf life
• Multicomponent kits for combination chemotherapy use
• Fixed-dose combinations (FDCs) on request

Our team ensures taste-masked, fast-dissolving, and easy-to-administer formulations for maximum patient compliance.

Quality Control and Assurance

Our in-house quality assurance and control laboratories operate under stringent SOPs to test each batch for:

• Assay and content uniformity
• Disintegration and dissolution profiling
• Sterility and endotoxin levels (for injectables)
• Impurity profiling and residual solvent testing
• Heavy metal limits and microbial contamination
• Stability testing (accelerated and long-term)

All processes follow IP, BP, USP, and WHO monographs, and are validated through robust QA systems before release.

Regulatory & Documentation Support

We offer complete regulatory documentation for domestic and international clients, including:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Stability Data (Zone II and IV compliance)
• Free Sale Certificate (FSC)
• WHO-GMP and ISO certificates
• Product Dossier (CTD, ACTD formats)
• Certificate of Origin (CoO)
• Material Safety Data Sheet (MSDS)
• Method of Analysis (MoA)

We provide regulatory guidance and document preparation for drug approvals in markets across Africa, Southeast Asia, the Middle East, and Latin America.

Private Labeling and Branding Solutions

We provide customized private label manufacturing with services that include:

• Brand design with client logo and color schemes
• Multilingual labeling for global exports
• Tamper-evident and child-resistant packaging
• Compliance with serialization and QR code standards
• Design of inserts and outer cartons

BluepillExpress supports distributors, hospitals, and retail brands with full design-to-dispatch packaging assistance.

Export and International Logistics

With active exports to over 35 countries, BluepillExpress offers:

• Freight forwarding via air or sea
• Pre-shipment inspection (SGS, Bureau Veritas, Intertek)
• Temperature-controlled supply chain (if needed)
• Harmonized system (HS) codes and export documentation
• Custom clearance support for regulated markets
• Tender bidding and government supply chain facilitation

Our logistics partners ensure reliable and compliant shipment of bulk consignments, sample kits, or retail packs globally.

Third-Party Manufacturing Process Flow

Our streamlined third-party production cycle includes:

1. Client Consultation & NDA
   • Product specification, artwork, regulatory scope, MOQ discussion
2. Quotation & Commercial Agreement
   • Cost finalization, delivery timelines, terms of trade
3. Product Development
   • Sample batch production and client approval (if applicable)
4. Artwork Finalization
   • Label, carton, insert design approvals with local language support
5. Commercial Production
   • WHO-GMP manufacturing with batch documentation
6. Quality Testing & Approval
   • CoA issuance, compliance checks, QA clearance
7. Packing & Dispatch
   • Final packaging, palletizing, export documentation, freight booking

Turnaround Time: 30–45 working days from artwork approval

Target Clients and Market Applications

Our Ondansetron third-party manufacturing services are ideal for:

• Generic pharmaceutical brands
• Oncology care suppliers
• Hospital and institutional procurement
• Pediatric and emergency care providers
• Distributors and pharmacy chains
• International tenders and health ministries

We cater to MOQs as low as 20,000 tablets/syrup units, and bulk orders up to millions of units, depending on client requirements.

Advantages of Partnering with BluepillExpress

• WHO-GMP certified, ISO-compliant manufacturing
• High-precision batch production and rapid scalability
• Wide range of dosage forms and strengths
• Customizable packaging and private label services
• Full regulatory support for global submissions
• Transparent communication and ethical partnership
• Competitive pricing without compromising quality

Conclusion

Ondansetron remains a critical pharmaceutical agent in the management of nausea and vomiting, particularly in cancer care, surgical recovery, and pediatrics. The demand for safe, effective, and accessible antiemetics continues to rise, especially in underserved markets and public health programs.

With its extensive manufacturing capabilities, regulatory expertise, and customer-centric approach, BluepillExpress is the ideal partner for companies looking to expand or launch Ondansetron-based product lines. Whether you’re fulfilling a national tender, launching a retail brand, or supplying hospitals, our team is here to deliver excellence at every step.