How to Source Nintedanib for Pharmaceutical Formulation

Nintedanib (Capsules, 100 mg, 150 mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Ofev (USA, EU), Vargatef (EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Nintedanib for formulation, R&D, or bulk manufacturing.

Product Overview: Nintedanib is an oral medication prescribed for the treatment of idiopathic pulmonary fibrosis (IPF)...

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

Nintedanib 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 Nintedanib 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 Nintedanib is more than procurement—it’s a strategic partnership. With its capsules form and 100 mg, 150 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 Nintedanib