How to Source Inavolisib for Pharmaceutical Formulation
Inavolisib (Tablets, 3mg, 9mg) is classified under Critical Care. It is therapeutically aligned with reference brands such as Itovebi (USA/EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Inavolisib for formulation, R&D, or bulk manufacturing.
Product Overview:
Inavolisib is a targeted oral PI3K-alpha inhibitor used in combination with palbociclib and fulvestrant for treating PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer. It not only inhibits the mutated PI3Kα enzyme but also promotes its degradation, selectively acting on cancer cells with PIK3CA mutations. The drug has shown strong efficacy in prolonging progression-free survival in clinical trials.
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
Inavolisib 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 Inavolisib 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 Inavolisib is more than procurement—it’s a strategic partnership. With its tablets form and 3mg, 9mg 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.
Next Step: Get expert assistance in sourcing Inavolisib.
Frequently Asked Questions For Sourcing of Inavolisib
What is the typical lead time for Inavolisib?
Lead times range from 4–6 weeks depending on supplier and region.
Is Inavolisib available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Inavolisib require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Inavolisib?
Yes, a DMF is available for regulated markets upon request. It includes detailed quality, manufacturing, and stability data.
Can I request samples or a pilot batch of Inavolisib?
Yes — pilot batches or samples can be arranged for R&D, stability studies, or formulation trials. MOQ may vary based on region and regulatory scope.
What compliance certificates are available for Inavolisib?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Inavolisib suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Inavolisib be used in fixed-dose combinations?
Yes — many formulations support inclusion in FDCs. Compatibility studies and formulation consultation are available on request.
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