How to Source Niraparib for Pharmaceutical Formulation

Niraparib (Capsule/ Tablet, 100 mg, 200 mg, 300 mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Zejula (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Niraparib for formulation, R&D, or bulk manufacturing.

Product Overview: Niraparib is an oral PARP inhibitor used for the treatment and maintenance of advanced ovarian, fallopian tube, or primary peritoneal cancer. It works by blocking the PARP enzyme, which helps repair DNA damage in cancer cells, leading to cell death, especially in tumors with BRCA mutations or homologous recombination deficiency (HRD). Niraparib is available in capsules or tablets and is taken once daily, with the dose adjusted based on body weight and platelet count. It helps delay cancer progression and is generally used after platinum-based chemotherapy.

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

Niraparib 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 Niraparib 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 Niraparib is more than procurement—it’s a strategic partnership. With its capsule/ tablet form and 100 mg, 200 mg, 300 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 Niraparib