How to Source Niraparib+Abiraterone for Pharmaceutical Formulation

Niraparib+Abiraterone (Tablet, 100mg+500mg / 200mg+1000mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as AKEEGA (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Niraparib+Abiraterone for formulation, R&D, or bulk manufacturing.

Product Overview: Niraparib/Abiraterone is an oral dual-action anticancer therapy used for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC). Niraparib is a PARP inhibitor that blocks DNA repair in cancer cells, leading to cell death, while Abiraterone acetate inhibits androgen biosynthesis, reducing tumor growth driven by male hormones. The combination is taken once daily with prednisone and is designed to improve treatment efficacy by targeting cancer through two complementary mechanisms. It is available as film-coated tablets in varying strengths.

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+Abiraterone 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+Abiraterone 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+Abiraterone is more than procurement—it’s a strategic partnership. With its tablet form and 100mg+500mg / 200mg+1000mg 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+Abiraterone