How to Source Octreotide acetate Pen for Pharmaceutical Formulation
Octreotide acetate Pen (injection (prefilled syringe), 25000 mcg, 7000 mcg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Bynfezia Pen (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Octreotide acetate Pen for formulation, R&D, or bulk manufacturing.
Product Overview:
Octreotide (brand Sandostatin®) is used to treat carcinoid tumors, acromegaly, and GEP-NETs. Available in subcutaneous injections (0.5 mg/mL, 1 mg/mL, 3 mg/mL) and long-acting formulations (Sandostatin LAR®) (10 mg, 20 mg, 30 mg), it controls tumor-related symptoms like diarrhea and flushing by inhibiting hormone release. Available through GMP-compliant suppliers in the US and EU for oncology treatment.
Octreotide, marketed under the brand name Sandostatin®, is a somatostatin analogue used in oncol...
Octreotide acetate Pen 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
Octreotide acetate Pen 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 Octreotide acetate Pen 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 Octreotide acetate Pen is more than procurement—it’s a strategic partnership. With its injection (prefilled syringe) form and 25000 mcg, 7000 mcg 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 Octreotide acetate Pen.
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Frequently Asked Questions For Sourcing of Octreotide acetate Pen
What is the typical lead time for Octreotide acetate Pen?
Lead times range from 4–6 weeks depending on supplier and region.
Is Octreotide acetate Pen available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Octreotide acetate Pen require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Octreotide acetate Pen?
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 Octreotide acetate Pen?
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 Octreotide acetate Pen?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Octreotide acetate Pen suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Octreotide acetate Pen 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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