How to Source Ibrutinib Capsules and tablets for Pharmaceutical Formulation

Ibrutinib Capsules and tablets (Capsules and tablets, Capsule:140 mg, 70 mg; Tablet: 140 mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Imbruvica®(US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Ibrutinib Capsules and tablets for formulation, R&D, or bulk manufacturing.

Product Overview: Ibrutinib (brand name Imbruvica®) is a BTK inhibitor used to treat B-cell malignancies like CLL, MCL, and Waldenström's macroglobulinemia. It works by blocking Bruton’s tyrosine kinase to prevent cancerous B-cell growth. Available in oral capsules (70 mg, 140 mg) and oral tablets (140 mg), it is approved in both the US and EU. Marketed by AbbVie and Janssen Pharmaceuticals, Imbruvica® is a crucial B2B oncology product for healthcare providers. Ibrutinib (brand name Imbruvica®) is a BTK inhibitor used in oncology and hematology to treat B-cell...

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

Ibrutinib Capsules and 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 Ibrutinib Capsules and 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 Ibrutinib Capsules and tablets is more than procurement—it’s a strategic partnership. With its capsules and tablets form and Capsule:140 mg, 70 mg; Tablet: 140 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 Ibrutinib Capsules and tablets