Bulk Pharmaceutical API Sources for lanreotide acetate

Bulk Pharmaceutical API Sources for lanreotide acetate

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-044-181-292
abcr GmbH		AB545272
MedChemexpress MCE		HY-P1959A
AbaChemScene		CS-0113779

Bulk Active Pharmaceutical Ingredient (API) Sources for: LANREOTIDE ACETATE

Last updated: July 28, 2025

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Introduction

Lanreotide Acetate is a synthetic analog of somatostatin, primarily used in the management of acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP-NETs). As a peptide-based API, its procurement hinges on specialized manufacturing processes and trusted supplier networks. Ensuring reliable sources for Lanreotide Acetate is vital for pharmaceutical companies to guarantee drug supply stability, regulatory compliance, and quality assurance. This article explores the global landscape of bulk API sourcing options for Lanreotide Acetate, focusing on key manufacturers, geographic considerations, regulatory environments, and supply chain dynamics.

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Overview of Lanreotide Acetate API Manufacturing

Lanreotide Acetate's complexity as a peptide API necessitates advanced synthetic methodologies, typically involving solid-phase peptide synthesis (SPPS), purification, and lyophilization. Its production is restricted to a handful of manufacturers with expertise in peptide synthesis, high-quality purification, and adherence to Good Manufacturing Practices (GMP). The primary criteria for sourcing include regulatory compliance (FDA, EMA, PMDA approvals), manufacturing capacity, quality consistency, and supply reliability.

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Major Global API Suppliers for Lanreotide Acetate

1.ipsen (Ipsen Pharma)

Ipsen, a renowned pharmaceutical company headquartered in France, is the original developer of Lanreotide. The company manufactures and supplies the Lanreotide Acetate API directly, ensuring high-quality standards aligned with regulatory specifications.

• Supply Capabilities: Ipsen’s integrated manufacturing process allows for consistent API production, often supplying active ingredients directly to their commercial products, such as Somatuline Depot.
• Regulatory Status: Fully compliant with major health authorities (FDA, EMA). Their API manufacturing facilities are GMP-certified.
• Strategic Advantage: Authorized and experienced in peptide synthesis, with a proven track record supplying both bulk API and finished drug products.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Hengrui Medicine, a leading Chinese biopharmaceutical player, has expanded into peptide APIs, including Lanreotide Acetate.

• Production Facilities: GMP-certified facilities capable of peptide synthesis and purification for global export.
• Market Position: Increasingly recognized for quality and cost-effective manufacturing, Hengrui supplies Asian markets and potentially international clients via third-party distributors.
• Regulatory Status: While approved in China, international regulatory approvals are ongoing; prospective buyers should perform due diligence.

3. Mylan / Viatris (Global)

Mylan, now part of Viatris, has a history of manufacturing peptide APIs, including somatostatin analogs, although direct production of Lanreotide API is less publicized.

• Manufacturing Expertise: Experienced in peptide synthesis and contract manufacturing.
• Supply Chain: Mylan has broad global manufacturing networks, with some facilities potentially capable of producing Lanreotide Acetate under contract.
• Regulatory Standing: Must verify GMP compliance and registration status in specific markets.

4. Shanghai Baite Biological Technology Co., Ltd.

A biotech company specializing in peptide APIs with emerging capabilities for Lanreotide Acetate.

• Facilities: GMP accreditation and experience in peptide synthesis.
• Market Focus: Mainly serving the Chinese pharmaceutical industry, with export potential.
• Regulatory Considerations: Buyers must confirm GMP certification and regulatory acceptability outside China.

5. Contract Manufacturing Organizations (CMOs) and Custom API Producers

Several specialized CMOs worldwide offer peptide API production services, including Lanreotide. These include:

• Bachem AG (Switzerland): Known for peptide synthesis and custom APIs but may not currently produce Lanreotide specifically.
• GenScript (China): Offers peptide SKU manufacturing, including custom synthesis; potential partner for scale-up or outsourcing.
• Sino Biopharmaceutical (China): Expanding peptide API production capabilities.

Manufacturers in this category typically produce API on a custom basis, with strict compliance to GMP standards and validated processes.

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Regional Considerations in API Sourcing

North America

The USA hosts a few established peptide API manufacturers with high regulatory standards, such as Lonza and Bachem. Their offerings focus on high purity and regulatory assurance, suitable for multinational pharmaceutical companies.

Europe

Ipsen’s manufacturing facilities are European-based, supporting global distribution. European regulators’ strict quality requirements make European suppliers preferable for Western markets.

Asia

China and India are significant players, with numerous biotech firms capable of peptide API manufacturing. Cost advantages are prominent, but due diligence regarding GMP standards and regulatory acceptance is critical.

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Regulatory and Quality Considerations

Sourcing Lanreotide Acetate API involves rigorous compliance with GMP standards, validated processes, and detailed documentation to facilitate regulatory approvals in target markets. Companies should seek suppliers with validated Quality Management Systems, extensive CMC (Chemistry, Manufacturing, and Controls) documentation, and proven track records for peptide APIs.

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Supply Chain Dynamics and Risk Management

Market stability depends on diversified sourcing strategies, including multiple suppliers across different regions. Dependency on a single source exposes companies to supply disruptions, quality lapses, or regulatory hurdles. Strategic partnerships and thorough supplier qualification processes are recommended, especially considering the complexity of peptide APIs.

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Emerging Trends and Future Outlook

• Biotech Innovation: Increasing use of recombinant DNA technology could streamline production, possibly reducing costs and enhancing scalability.
• Regulatory Harmonization: Global frameworks improving acceptance of peptide APIs from Asian manufacturers will improve supply options.
• Supply Chain Resilience: Pandemic-induced disruptions have accelerated the diversification of API sources, emphasizing the importance of multiple qualified suppliers.

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Key Takeaways

• Ipsen remains the primary expert and manufacturer for Lanreotide Acetate API, offering high-quality, regulated products.
• Asian manufacturers, notably Chinese firms, are expanding in peptide API production, offering cost-effective alternatives but require thorough validation.
• Contract manufacturing organizations (CMOs) provide flexible production options, with the ability to scale and customize.
• Regulatory diligence and quality assurance are critical when sourcing from new or emerging suppliers.
• Diversification of API sourcing sources enhances supply chain resilience and mitigates risks associated with geopolitical or regulatory disruptions.

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FAQs

1. Is Ipsen the only legitimate supplier of Lanreotide Acetate API?
No. While Ipsen is the original manufacturer and maintains high standards, several other companies, especially in China and India, are developing peptide API capabilities, including potential suppliers of Lanreotide Acetate. However, buyers must verify regulatory compliance and GMP certification.

2. Can Chinese suppliers meet international regulatory standards for Lanreotide API?
Some Chinese manufacturers have achieved GMP certification and export approval to Western markets. Due diligence, including site audits and validation documentation, is essential to ensure compliance.

3. How does the cost of Lanreotide Acetate API vary across regions?
Asian manufacturers generally offer lower prices due to cost advantages but may face challenges related to regulatory acceptance and quality assurance, which should be carefully evaluated.

4. What are the key quality attributes to assess in API sourcing?
Purity (>99%), endotoxin levels, residual solvents, and compliance with pharmacopoeial standards are critical. Additionally, manufacturers should provide comprehensive batch documentation, stability data, and GMP certification.

5. What is the future outlook for Lanreotide Acetate API sourcing?
The growing demand for peptide APIs and advances in biotechnological manufacturing are likely to diversify and expand supply options. Enhanced regulatory harmonization and technological innovation may improve availability and reduce costs globally.

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References

[1] Ipsen. "Somatuline Depot (Lanreotide) – Product Information," Ipsen, 2022.
[2] GlobalData. "Peptide API Market Insights," 2022.
[3] GMP Certification Reports, Chinese Regulatory Authority (NMPA), 2022.
[4] Pharmaceutical Technology. "Emerging Peptide API Manufacturers," 2021.
[5] U.S. Food and Drug Administration (FDA). "Guidance for Industry: API Manufacturing Standards," 2022.