LANREOTIDE ACETATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193	ANDA	Cipla USA Inc.	69097-906-67	1 POUCH in 1 CARTON (69097-906-67) / 1 SYRINGE in 1 POUCH / .5 mL in 1 SYRINGE	2025-05-30
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193	ANDA	Cipla USA Inc.	69097-907-67	1 POUCH in 1 CARTON (69097-907-67) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE	2025-05-30
Invagen Pharms	LANREOTIDE ACETATE	lanreotide acetate	SOLUTION;SUBCUTANEOUS	217193	ANDA	Cipla USA Inc.	69097-908-67	1 POUCH in 1 CARTON (69097-908-67) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE	2025-05-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Lanreotide acetate is a long-acting somatostatin analog primarily used in the treatment of acromegaly and neuroendocrine tumors (NETs). As a critical therapeutic agent, its accurate sourcing and supply chain management are paramount for healthcare providers, pharmaceutical manufacturers, and patients. This report explores the key suppliers, manufacturing trends, regulatory considerations, and market dynamics influencing lanreotide acetate procurement.

Overview of Lanreotide Acetate

Lanreotide acetate is administered via deep subcutaneous injection, offering sustained suppression of hormone secretion associated with neuroendocrine tumors. Its pharmacokinetic profile allows for dosing intervals of 4 to 8 weeks, enhancing patient compliance and quality of life. The drug is commercially available under brand names such as Somatuline Autogel® (Ipsen) and SōmaMed®, but several suppliers produce active pharmaceutical ingredients (APIs) and finished formulations globally.

Major Suppliers of Lanreotide Acetate API

1. Ipsen Pharma

Ipsen, the originator of lanreotide, supplies it under the structured brand and maintains control over its proprietary manufacturing process for the API as well as finished drug product (FDP). Ipsen’s integrated supply chain ensures consistent quality, regulatory compliance, and global distribution. Their manufacturing facilities adhere to Good Manufacturing Practices (GMP), and Ipsen’s extensive distribution network makes its products widely accessible across North America, Europe, and emerging markets [1].

2. Manufacturers of Lanreotide Acetate API

Beyond Ipsen, several contract manufacturing organizations (CMOs) and API producers supply bulk lanreotide acetate, often for regional pharmaceutical companies or generic drug producers:

Novartis AG: While primarily known for its own portfolio, Novartis has reported involvement in peptide APIs, including long-acting somatostatin analogs, leveraging peptide synthesis expertise. Their capacity may extend to nano- and micro-scale peptide manufacturing, although specific supplies of lanreotide acetate are not publicly confirmed [2].
Chemo Group (China): This Chinese CMO claims a strong peptide API manufacturing capability, including somatostatin analogs. Their offerings include GMP-grade lanreotide API targeted at regional markets and international clients [3].
Shree Bioscience (India): Specializes in peptide synthesis, offering customized peptide APIs. Their production of lanreotide acetate APIs is under GMP compliance, targeting both domestic and export markets.
Mitsubishi Tanabe Pharma Corporation (Japan): Known for peptide synthesis and complex biologics, potentially supplying or partnering for lanreotide API production, particularly for the Asia-Pacific market.

3. Emerging Generic and Biosimilar Suppliers

With patent expirations, generic producers have entered the landscape:

Sandoz (Novartis division): Positioned as a global leader in biosimilars and generics, Sandoz has the expertise to produce peptide-based drugs, including somatostatin analogs, contingent upon patent status and regulatory pathways.
Fresenius Kabi: Involved in peptide and hormone manufacturing, their capacity to produce lanreotide acitate APIs and formulations positions them as a potential supplier, especially for markets seeking cost-effective alternatives.

Finished Drug Manufacturers and Suppliers

While some suppliers produce APIs, many pharmaceutical companies outsource formulation manufacturing to specialized contract manufacturing organizations (CMOs). Key points include:

Ipsen’s Proprietary Formulation: Predominantly supplied under the Somatuline brand, Ipsen maintains tight control over manufacturing, distribution, and marketing.
Generic and Biosimilar Makers: Companies such as Mylan (now Viatris), Hikma Pharmaceuticals, and Dr. Reddy’s Laboratories have developed generic formulations, often sourcing APIs from third-party suppliers.

4. Regional and Local Suppliers

India and China: Peptide biosynthesis expertise enables regional players to manufacture lanreotide acetate APIs, often targeting local markets or export.
Eastern Europe and Eastern Asia: Companies such as BioPartners (Czech Republic) and Zhejiang Hailan Pharmaceutical (China) are expanding peptide API portfolios, including long-acting somatostatin analogs.

Regulatory and Quality Considerations

Packaging, batch consistency, purity, and stability are critical. Suppliers must conform to international standards:

GMP Compliance: Mandatory for APIs and finished products to ensure safety and efficacy.
Certifications: ISO standards, regulatory approvals from FDA, EMA, and PMDA influence supplier credibility.
Traceability and Transparency: Increasingly demanded to prevent counterfeit drugs and ensure supply chain integrity.

Market Dynamics and Supply Chain Risks

The reliance on a limited number of API manufacturers, especially from China and India, poses risks such as:

Supply Disruptions: Political tensions, trade restrictions, or manufacturing issues can disturb supply.
Pricing Pressures: Generic competition and biosimilar proliferation exert downward pressure on prices.
Regulatory Stringency: Enhanced quality controls and regional approval pathways may prolong rollout timelines.

To mitigate risks, pharmaceutical companies actively diversify supplier bases and maintain strategic inventories.

Emerging Trends and Future Outlook

Considering patent expirations and biosimilar development, the lanreotide acetate supply landscape is poised for expansion:

Development of Biosimilar Versions: Several companies are developing biosimilar somatostatin analogs, aiming for lower-cost options.
Technological Advancements: Enhanced peptide synthesis techniques, including solid-phase peptide synthesis (SPPS), may reduce costs and increase production efficiency.
Supply Chain Optimization: Blockchain and other digital tools are increasingly used to improve traceability and transparency.

Key Takeaways

Dominant Supplier: Ipsen remains the primary source for high-quality, GMP-compliant lanreotide acetate API and finished products globally.
Diversification: Regional manufacturers in China, India, and Japan serve as alternative suppliers, especially in emerging markets.
Regulatory Compliance: Suppliers must meet international quality standards; vigilance on GMP adherence is essential.
Market Risks: Supply chain vulnerabilities necessitate strategic sourcing and inventory management.
Growth Opportunities: The biosimilar market and technological advancements offer avenues for cost reduction and increased access.

FAQs

1. Who are the main global suppliers of lanreotide acetate API?
Ipsen is the original manufacturer and major supplier, with additional API manufacturing by Chinese companies like Chemo Group, and Indian firms such as Shree Bioscience. Large pharma giants like Novartis and Mitsubishi Tanabe also possess peptide synthesis expertise relevant to the space.

2. Are generic versions of lanreotide acetate available?
Yes, generic and biosimilar versions have entered markets, typically produced by companies in India, China, and Eastern Europe, often leveraging third-party APIs.

3. What quality standards should API suppliers meet for lanreotide acetate?
Suppliers must comply with Good Manufacturing Practices (GMP), possess appropriate certifications (e.g., ISO, FDA approval), and demonstrate consistent batch quality and traceability.

4. How do supply chain disruptions impact lanreotide acetate availability?
Disruptions from geopolitical tensions, manufacturing hiccups, or regulatory delays can hinder supply, necessitating diversification and inventory buffers.

5. What are future trends in the lanreotide acetate supply market?
The biosimilar pipeline is growing, technological innovations in peptide synthesis will reduce costs, and supply chain transparency measures are enhancing product integrity.

References

[1] Ipsen. "Lanreotide (Somatuline Autogel): Product Information." Ipsen Pharmaceuticals, 2022.

[2] Novartis. "Peptide Manufacturing Capabilities." Novartis Annual Report, 2021.

[3] Chemo Group. "Peptide API Production." Corporate Brochure, 2022.

Suppliers and packagers for generic pharmaceutical drug: LANREOTIDE ACETATE