How to Source Paliperidone Extended-Release Tablets for Pharmaceutical Formulation

Paliperidone Extended-Release Tablets (Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, 9 mg) is classified under Antipsychotropic Drugs. It is therapeutically aligned with reference brands such as Invega®(US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Paliperidone Extended-Release Tablets for formulation, R&D, or bulk manufacturing.

Product Overview: Paliperidone is an atypical antipsychotic that works by blocking dopamine D2 and serotonin 5-HT2A receptors, helping to reduce symptoms of schizophrenia and improve mood stability. The extended-release (ER) tablets use an OROS delivery system to provide steady plasma levels over 24 hours, minimizing fluctuations and side effects. They are used for the treatment of schizophrenia and schizoaffective disorder in adults.

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

Paliperidone Extended-Release Tablets 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 Paliperidone Extended-Release Tablets 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 Paliperidone Extended-Release Tablets is more than procurement—it’s a strategic partnership. With its extended-release tablets form and 1.5 mg, 3 mg, 6 mg, 9 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 Paliperidone Extended-Release Tablets