Suppliers and packagers for generic pharmaceutical drug: LOTILANER

LOTILANER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603	NDA	Tarsus Pharmaceuticals, Inc.	81942-125-01	1 BOTTLE, DROPPER in 1 CARTON (81942-125-01) / 10 mL in 1 BOTTLE, DROPPER	2023-08-14
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603	NDA	Tarsus Pharmaceuticals, Inc.	81942-125-99	1 BOTTLE, DROPPER in 1 CARTON (81942-125-99) / 1.5 mL in 1 BOTTLE, DROPPER	2023-08-14

Suppliers for the Pharmaceutical Drug: LOTILANER

Last updated: July 30, 2025

Introduction

In the pharmaceutical landscape, identifying reliable suppliers for specific drugs such as LOTILANER (also known as Lanreotide) is crucial for healthcare providers, distributors, and pharmaceutical companies. As a long-acting somatostatin analog primarily used in the treatment of acromegaly and neuroendocrine tumors, LOTILANER's supply chain stability directly impacts patient care and commercial operations. This article offers a comprehensive analysis of the current suppliers, manufacturing landscape, distribution channels, and strategic considerations relevant to LOTILANER.

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Overview of LOTILANER (Lanreotide)

Pharmacological Profile:
LOTILANER is marketed under the generic name Lanreotide. It is a synthetic analog of somatostatin with extended activity. The drug is administered via deep subcutaneous injection, typically as a long-acting depot formulation. Its therapeutic efficacy hinges on manufacturing quality and supply chain integrity.

Approved Indications:

• Acromegaly management
• Unresectable or metastatic neuroendocrine tumors (NETs), specifically carcinoid tumors

Regulatory Status:
LOTILANER primarily benefits from regulatory approvals in Europe, the United States (via the brand's marketed formulation), and other jurisdictions, with availability contingent on manufacturing and distribution agreements.

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Key Manufacturers and Suppliers

1. Ipsen Pharma

Background and Market Role:
Ipsen Pharma, a European biopharmaceutical company, originally developed and markets Somatuline Autogel (the commercial product for Lanreotide). It's the primary manufacturer of LOTILANER under licensing agreements. Ipsen’s robust manufacturing facilities in France and Europe ensure a continuous supply chain.

Manufacturing Capabilities:

• Extensive production facilities in France
• Global distribution networks
• Focused R&D for formulation improvements

Supply Chain Strategy:
Ipsen maintains strategic stockpiles and leverages multiple manufacturing sites to mitigate regional disruptions. The company also collaborates with third-party logistics providers to ensure timely distribution worldwide.

2. Strategic Licensing and Contract Manufacturing Partners

While Ipsen is the core producer, certain regional markets may deploy contract manufacturing organizations (CMOs) to satisfy local demand, especially in emerging markets. These CMOs possess the requisite biopharmaceutical manufacturing capabilities for sterile injectable drugs, including Lanreotide formulations.

Notable Contract Partners Include:

• Althea Technologies: U.S.-based CMO specializing in sterile injectables.
• Bionpharma: U.S. manufacturer licensed for generic formulations.
• Laboratoires Renaudin (France): Regional contract manufacturer.

3. Regional Distributors and Wholesalers

In markets where Ipsen's direct distribution does not extend, authorized regional distributors procure LOTILANER from Ipsen or CMOs and distribute via pharmaceutical wholesalers. Major players include:

• McKesson Corporation: U.S.
• Cardinal Health: Multiple markets
• Alliance Healthcare: Europe
• Phoenix Pharma: Asia-Pacific

These distributors ensure supply continuity and logistics management, especially critical in regions with complex import/export or regulatory hurdles.

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Supply Chain Challenges and considerations

Manufacturing Disruptions:
Global supply chains for biologics are susceptible to disruptions from raw material shortages, manufacturing delays, or regulatory compliance issues. Ipsen’s reliance on proprietary manufacturing processes means any disturbance impacts overall supply.

Regulatory Approvals and Market Access:
Different regions require local regulatory approvals, which can delay product availability unless local manufacturers or licensing partners are established.

Global Demand Dynamics:
The growing prevalence of acromegaly and neuroendocrine tumors intensifies demand. Ipsen has responded with capacity expansion, including new facilities and partnerships, to meet global needs.

Patent and Patent Expiry Impact:
The patent status of Lanreotide influences production licenses and the entry of generic alternatives, which could alter supply dynamics and pricing strategies.

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Emerging Suppliers and Future Outlook

With patent expiration in certain jurisdictions anticipated or already realized, generic and biosimilar manufacturers aim to enter the marketplace. Companies such as Sandoz and Teva Pharmaceuticals are exploring or have launched biosimilar versions of Lanreotide, potentially diversifying supply sources.

Key trends include:

• Expansion of biosimilar manufacturing capacity
• Increased regional manufacturing alliances in emerging markets
• Strategic licensing deals to enhance supply resilience

Furthermore, Ipsen continues investing in process innovation and manufacturing excellence, seeking to streamline supply and reduce production costs.

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Critical Considerations for Stakeholders

• Supply Security: Primary reliance on Ipsen necessitates ongoing evaluation of their manufacturing capacity and contingency plans.
• Regulatory Landscape: Access may depend on regional regulatory approvals; engaging with local authorities is critical for market entry.
• Quality Assurance: Ensuring supplier compliance with Good Manufacturing Practices (GMP) is essential for patient safety.
• Pricing and Market Competition: The entrance of biosimilars amplifies price competition, influencing procurement strategies.

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Key Takeaways

• Ipsen Pharma remains the dominant supplier for LOTILANER through direct manufacturing and licensing agreements, with regional distributors playing an essential role in supply chain distribution.
• The emergence of biosimilars is poised to diversify the supply landscape, potentially reducing costs and increasing accessibility.
• Manufacturing disruptions and regulatory delays are inherent risks; stakeholders should develop strategic contingencies, including alternative sourcing options.
• Regional manufacturing alliances and contract manufacturing are increasingly vital, particularly in emerging markets, to ensure supply resilience.
• Strategic engagement with manufacturers and regulators is essential for securing consistent supply amid market growth and patent expirations.

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FAQs

1. Who are the primary manufacturers of LOTILANER?
Ipsen Pharma is the main manufacturer and marketer of LOTILANER (Lanreotide). Partnered with contract manufacturing organizations and regional distributors to ensure global supply.

2. Are there biosimilar versions of LOTILANER available?
While specific biosimilars are in development, authorized biosimilar Lanreotide products are emerging in certain markets, potentially increasing supply options in the future.

3. How does regulatory approval affect LOTILANER supply?
Regulatory approval is critical for legal distribution. Delays or restrictions in approval processes can temporarily constrict supply, especially during market entry phases.

4. What risks threaten the supply chain of LOTILANER?
Manufacturing disruptions, raw material shortages, regulatory hurdles, and patent expirations pose significant risks to consistent product availability.

5. How can healthcare organizations ensure continual access to LOTILANER?
Developing relationships with multiple suppliers, engaging with authorized distributors, monitoring regulatory updates, and planning for biosimilar options are best practices to ensure supply continuity.

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References

[1] Ipsen Pharma. Somatuline Autogel (Lanreotide) Prescribing Information. (2022).
[2] U.S. Food and Drug Administration. Lanreotide Prescribing Information. (2022).
[3] European Medicines Agency. EMA approval details for Lanreotide. (2022).
[4] Market research reports on biosimilar development in neuroendocrine therapies. (2023).
[5] Global Pharmaceutical Supply Chain Analysis. (2022).