Suppliers and packagers for MYCAPSSA

MYCAPSSA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232	NDA	Chiesi USA, Inc.	10122-550-28	4 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	2020-07-06
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232	NDA	Amryt Pharmaceuticals Designated Activity Company	69880-120-28	4 BLISTER PACK in 1 DOSE PACK (69880-120-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	2020-07-06

Suppliers for the Pharmaceutical Drug: MYCAPSSA

Last updated: July 29, 2025

Introduction

MYCAPSSA (pasireotide) is an oral formulation of the somatostatin analog used primarily for the management of acromegaly and Cushing’s disease in adults. Developed by Crinetics Pharmaceuticals and marketed by Strongbridge Biopharma, MYCAPSSA offers a novel, non-invasive treatment option, filling a significant therapeutic gap for patients requiring long-term management. Its complex manufacturing process, high barrier for entry, and reliance on specialized suppliers make the identification of reliable sourcing channels critical for stakeholders across the supply chain. This comprehensive analysis explores the key suppliers involved in the production, formulation, excipient sourcing, packaging, and distribution of MYCAPSSA.

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Manufacturing of Active Pharmaceutical Ingredient (API): Pasireotide

The cornerstone of MYCAPSSA’s supply chain resides in its API, pasireotide. As a peptide-based drug, pasireotide synthesis demands specialized expertise in peptide synthesis, high-purity production, and stringent quality controls.

Primary API Suppliers

1. Contract Manufacturing Organizations (CMOs):

Given the complexity and high standards for peptide APIs, Crinetics Pharmaceuticals typically contracts with specific CMOs that possess the infrastructure for large-scale peptide synthesis. Some notable companies include:

• Lonza: A global leader in peptide synthesis, Lonza offers custom manufacturing of peptides, including APIs, with facilities compliant with cGMP standards. They feature expertise in scalable peptide production with rigorous quality control.

• Bachem: Bachem specializes in custom peptide synthesis and has been involved in supplying APIs for numerous peptide-based pharmaceuticals. Their facilities are certified for GMP production and they have experience with complex peptides like pasireotide.

• Samsung Biologics: Recently expanding into peptide API production, Samsung offers comprehensive manufacturing services, including peptide synthesis at scale, supported by advanced bioprocessing infrastructure.

Note: The actual sourcing of pasireotide API is often governed by confidentiality and contractual agreements, so specific supplier details are usually proprietary.

Chemical Synthesis and Raw Material Suppliers

Key raw materials involve amino acids, solvents, and coupling reagents critical in peptide synthesis. These are procured from:

• Thermo Fisher Scientific
• Sigma-Aldrich (Merck)
• EMD Millipore

The sourcing of these raw materials follows strict quality protocols to ensure API purity.

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Formulation and Production of MYCAPSSA

MYCAPSSA’s distinctive feature is its oral capsule formulation of pasireotide, necessitating specialized formulation capabilities for bioavailability and stability.

Excipient Suppliers

The formulations rely on excipients such as:

• Diluents and fillers: Microcrystalline cellulose, lactose — supplied by suppliers like DuPont Nutrition & Health and Meggle.
• Disintegrants and binders: Cross-linked sodium carboxymethyl cellulose, povidone — sourced from Ashland or BASF.
• Capsule shells: Gelatin or HPMC capsules, from Capscan or ACG worldwide.

Formulation and Capsule Manufacturing Partners

Manufacturing of MYCAPSSA capsules occurs at facilities with the following capabilities:

• Contract Fill-Finish Organizations (FFOs): Companies like Catalent, Patheon (Thermo Fisher), and Recipharm possess expertise in oral solid dosage form manufacturing, ensuring compliance with GMP and regulatory standards specific to encapsulated peptides.

• Specialized Coatings and Encapsulation Technologies: These firms utilize advanced coating techniques to enhance capsule stability and drug release profiles.

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Packaging, Labeling, and Distribution

Proper packaging preserves drug stability and ensures compliance with safety standards.

• Primary Packaging Suppliers: Blister pack manufacturers like Stevanato Group and Gerresheimer provide blister packs with features suitable for preserving peptide stability and preventing moisture ingress.

• Secondary Packaging: Labeling and cartons are sourced from custom suppliers, with meticulous validation for tamper-evidence and traceability.

Distribution Channels

Distribution partners with cold chain logistics capacity include:

• FedEx Custom Critical and DHL Medical Express — providing temperature-controlled logistics essential for peptide-based drugs.

Regulatory and Quality Standards

Suppliers involved in MYCAPSSA’s supply chain must meet strict regulatory standards, including FDA’s cGMP, EMA GMP, and ISO certifications, ensuring safety, efficacy, and quality.

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Supply Chain Challenges and Strategic Considerations

The manufacturing of MYCAPSSA presents notable challenges:

• Peptide API Complexity: Peptide synthesis requires highly specialized facilities and control, which limits the number of qualified suppliers.
• Supply Chain Disruptions: Raw material shortages, geopolitical issues, and regulatory changes can impact availability.
• Quality Assurance: Maintaining consistent API quality necessitates rigorous supplier qualification and ongoing monitoring.

Crinetics’ strategic partnerships with specialized CMOs like Lonza and Bachem mitigate some risks by leveraging proven manufacturing expertise.

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Conclusion

The supply chain for MYCAPSSA involves a network of specialized partners covering API synthesis, formulation, encapsulation, packaging, and logistics. The critical reliance on peptide manufacturers like Lonza and Bachem underscores the complexity of supplying a peptide-based oral medication. Ensuring robust supply chains requires maintaining strategic supplier relationships, rigorous quality standards, and proactive risk management.

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Key Takeaways

• MYCAPSSA’s core supplier relationships revolve around peptide API manufacturers with established GMP compliance, notably Lonza and Bachem.
• Raw material sourcing for peptide synthesis is highly regulated, involving reputable suppliers of amino acids and reagents.
• Formulation, capsule manufacturing, and packaging depend on specialized CMOs and suppliers capable of handling peptide stability and bioavailability challenges.
• Cold chain logistics are vital for maintaining drug integrity during distribution.
• Strategic partnerships and supplier qualification are essential to mitigate supply disruptions and ensure consistent product quality.

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FAQs

1. Who are the primary API suppliers for MYCAPSSA?
The API, pasireotide, is typically supplied by specialized peptide manufacturing CMOs such as Lonza and Bachem, which possess the technological expertise and GMP compliance required for complex peptide synthesis.

2. How is the raw material supply chain managed for MYCAPSSA?
Raw materials like amino acids are sourced from established suppliers such as Sigma-Aldrich and Thermo Fisher Scientific, adhering to strict quality and purity standards essential for peptide synthesis.

3. What companies handle the formulation and capsule production of MYCAPSSA?
Contract manufacturing organizations like Catalent and Recipharm are responsible for the formulation, encapsulation, and fill-finish processes, ensuring pharmaceutical standards are maintained.

4. What are the logistical considerations for distributing MYCAPSSA?
Due to its peptide nature, MYCAPSSA requires temperature-controlled cold chain logistics during transportation, handled by logistics providers like DHL Medical Express and FedEx Custom Critical.

5. What future supply chain risks should stakeholders monitor?
Risks include raw material shortages, geopolitical conflicts impacting manufacturing facilities, regulatory changes, and capacity limitations at critical manufacturing centers. Diversification of suppliers and robust quality management can mitigate these risks.

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References

[1] Crinetics Pharmaceuticals. (2022). MYCAPSSA (pasireotide) Oral Capsules: Product Information.
[2] Bachem. (2023). Custom Peptide Manufacturing Capabilities.
[3] Lonza. (2023). Peptide Synthesis and API Production Services.
[4] FDA. (2021). Good Manufacturing Practice (GMP) Regulations for Drugs.
[5] Pharmtech. (2022). The Challenges of Peptide API Manufacturing in Modern Pharma.