How to Source Ziv-aflibercept for Pharmaceutical Formulation
Ziv-aflibercept (Intravenous (IV), 25mg/ml) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Zaltrap® (US & EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Ziv-aflibercept for formulation, R&D, or bulk manufacturing.
Product Overview:
Ziv-aflibercept (brand name Zaltrap®) is a recombinant fusion protein used in oncology to treat metastatic colorectal cancer (mCRC) by inhibiting angiogenesis. It targets vascular endothelial growth factor (VEGF), preventing tumor blood vessel growth. Available as an intravenous (IV) injection with a strength of 25 mg/mL, it is used in combination with chemotherapy for mCRC treatment. Ziv-aflibercept is available in both the US and EU, helping improve outcomes for patients with advanced colorectal cancer.
Ziv-aflibercept (brand name Zaltrap®) is a recombinant fusion protein used in oncology to treat meta...
Ziv-aflibercept API – ideal for compliant pharmaceutical formulation.
Quick Insight: Over 60% of formulation delays are linked to poor API sourcing. A well-planned sourcing strategy can reduce risk and accelerate market entry.
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
Ziv-aflibercept 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 Ziv-aflibercept is 4–6 weeks.
- ✔ Emergency dispatch options
- ✔ Regional warehousing
- ✔ Special storage if needed
6. Formulation Support
- ✔ Technical datasheets
- ✔ Sample availability
- ✔ Stability study support
Pro Tip: Engage supplier formulation experts early — it can improve bioavailability and cut development time.
Conclusion
Sourcing Ziv-aflibercept is more than procurement—it’s a strategic partnership. With its intravenous (iv) form and 25mg/ml 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 Ziv-aflibercept.
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Frequently Asked Questions For Sourcing of Ziv-aflibercept
What is the typical lead time for Ziv-aflibercept?
Lead times range from 4–6 weeks depending on supplier and region.
Is Ziv-aflibercept available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Ziv-aflibercept require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Ziv-aflibercept?
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 Ziv-aflibercept?
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 Ziv-aflibercept?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Ziv-aflibercept suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Ziv-aflibercept 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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