How to Source Lanreotide for Pharmaceutical Formulation
Lanreotide (Injection, 60 mg, 90 mg, 120 mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as omatuline Depot (USA), Somatuline Autogel (USA). This guide highlights key sourcing factors buyers should consider when procuring high-quality Lanreotide for formulation, R&D, or bulk manufacturing.
Product Overview:
Lanreotide is a synthetic octapeptide analogue of somatostatin. It binds to somatostatin receptors (SSTR‑2 and SSTR‑5), inhibiting secretion of growth hormone and other hormones. It is used to treat Acromegaly when surgery/radiotherapy are not suitable and to manage certain neuroendocrine tumours, including gastrointestinal/pancreatic NETs and symptoms of Carcinoid syndrome.
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
Lanreotide 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 Lanreotide 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 Lanreotide is more than procurement—it’s a strategic partnership. With its injection form and 60 mg, 90 mg, 120 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.
Next Step: Get expert assistance in sourcing Lanreotide.
Frequently Asked Questions For Sourcing of Lanreotide
What is the typical lead time for Lanreotide?
Lead times range from 4–6 weeks depending on supplier and region.
Is Lanreotide available in multiple grades?
Yes — common grades include USP, EP, and JP. Verify grade suitability for your dosage form before purchase.
Does Lanreotide require special storage?
It should be stored in a cool, dry place away from direct sunlight.
Is a Drug Master File (DMF) available for Lanreotide?
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 Lanreotide?
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 Lanreotide?
Available documentation may include GMP, ISO 9001, ISO 14001, and ICH Q7 certificates, along with CoA, TDS, and stability data.
Is Lanreotide suitable for regulated markets like US/EU?
Yes — compliant with EU/US/WHO GMP standards and available with regulatory support documentation for filings.
Can Lanreotide 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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