How to Source olanzapine + samidorphan for Pharmaceutical Formulation

olanzapine + samidorphan (Tablets, 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg) is classified under Antipsychotropic Drugs. It is therapeutically aligned with reference brands such as Lybalvi (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality olanzapine + samidorphan for formulation, R&D, or bulk manufacturing.

Product Overview: Olanzapine/samidorphan is a fixed‑dose combination medication combining the atypical antipsychotic olanzapine with the opioid receptor antagonist samidorphan. Olanzapine manages psychiatric symptoms such as hallucinations, delusions, mania, or mixed episodes by acting on brain neurotransmitters. Samidorphan helps reduce the risk of weight gain and metabolic side effects commonly seen with olanzapine alone, improving tolerability and long‑term adherence.

1. Regulatory Compliance & Documentation

Ensure suppliers provide:

• ✔ Valid DMF (Drug Master File)
• ✔ COA (Certificate of Analysis) for each batch
• ✔ GMP, ISO, or ICH Q7 compliance certificates

2. Purity, Grade & Specification Matching

olanzapine + samidorphan must meet exact grade and purity for your dosage form:

• ✔ USP / EP / JP grade verification
• ✔ Particle size distribution check
• ✔ Residual solvent and heavy metal limits

3. Supplier Reliability & Audit History

• ✔ Positive past audit reports
• ✔ Pharma client references
• ✔ Years of proven API manufacturing experience

4. Commercial Terms: Pricing, MOQ & Flexibility

• ✔ Transparent pricing
• ✔ Pilot batch MOQ flexibility
• ✔ Volume-based discounts

5. Lead Time, Inventory & Logistics

Typical lead time for olanzapine + samidorphan is 4–6 weeks.

• ✔ Emergency dispatch options
• ✔ Regional warehousing
• ✔ Special storage if needed

6. Formulation Support

• ✔ Technical datasheets
• ✔ Sample availability
• ✔ Stability study support

Conclusion

Sourcing olanzapine + samidorphan is more than procurement—it’s a strategic partnership. With its tablets form and 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.

Frequently Asked Questions For Sourcing of olanzapine + samidorphan