Suppliers and packagers for camzyos

camzyos

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998	NDA	Myokardia, Inc.	73625-111-11	30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (73625-111-11)	2022-04-28
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998	NDA	Myokardia, Inc.	73625-112-11	30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (73625-112-11)	2022-04-28
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998	NDA	Myokardia, Inc.	73625-113-11	30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (73625-113-11)	2022-04-28
Bristol	CAMZYOS	mavacamten	CAPSULE;ORAL	214998	NDA	Myokardia, Inc.	73625-114-11	30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (73625-114-11)	2022-04-28

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: CAMZYOS

Introduction
CAMZYOS (mavacamten) is an innovative cardiology medication developed by Bristol-Myers Squibb, primarily indicated for the treatment of obstructive hypertrophic cardiomyopathy (HCM). As a novel therapy targeting myosin-actin interactions to reduce left ventricular outflow tract obstruction, CAMZYOS’s supply chain is critical for healthcare providers, patients, and stakeholders. This report examines the current suppliers involved in manufacturing, raw material sourcing, and distribution channels, alongside the implications for market stability and regulatory considerations.

Manufacturing and Development Background
Bristol-Myers Squibb (BMS) developed CAMZYOS after acquiring MyoKardia, a biopharmaceutical company specializing in targeted therapies for cardiovascular diseases. The drug's manufacturing process involves complex synthesis stages of mavacamten, a small-molecule allosteric modulator influencing cardiac myosin activity. Due to the sophisticated nature of its formulation, the supply chain relies on specific, highly regulated suppliers for raw materials, active pharmaceutical ingredients (APIs), and excipients.

Key Suppliers for Raw Materials and APIs

1. Active Pharmaceutical Ingredient (API) Suppliers
The API for CAMZYOS is synthesized following proprietary processes, often involving multiple chemical intermediates. BMS has partnered with several specialized contract manufacturing organizations (CMOs) to produce mavacamten’s API, ensuring high quality, regulatory compliance, and supply security. Known API suppliers include:

• AbbVie (formerly a collaborator) — Historically, AbbVie’s research collaborations included API development for similar compounds, but current specifics for mavacamten are under BMS's control.
• External Contract Manufacturing Organizations (CMOs):
  • Catalent Pharma Solutions — Catalent offers global contract manufacturing services, including fine chemical synthesis and scale-up for APIs involved in cardiovascular therapies.
  • Lonza — A leading CMO specializing in chemical synthesis for complex APIs, capable of producing mavacamten at commercial scale under GMP standards.
  • Thermo Fisher Scientific — Offers custom synthesis and manufacturing services, potentially serving as a supplier for specific intermediates or final APIs.

2. Excipients and Formulation Components
CAMZYOS’s formulation entails pharmaceutical excipients compliant with FDA and EMA standards. Suppliers of these excipients include:

• BASF — Produces pharmaceutical-grade excipients such as fillers, binders, and disintegrants used in tablets.
• Evonik — Supplies advanced excipients, including polymers and binding agents compatible with cardiac medications.
• Jubilant Life Sciences — Provides various formulation excipients globally, with a focus on quality and scalability.

3. Intermediates and Chemical Reagents
The synthesis pathway of mavacamten involves specialized intermediates sourced from chemical suppliers with strict regulatory oversight. These include:

• Sigma-Aldrich (Merck) — Supplies high-purity reagents and intermediates for pharmaceutical manufacturing, including specialized chemicals involved in the synthesis process.
• Alfa Aesar — Provides a broad spectrum of chemical intermediates necessary for complex synthesis routes.

Distribution Channels and Logistics

Once manufactured, CAMZYOS is distributed through a network managed by Bristol-Myers Squibb’s global distribution infrastructure. The company partners with major pharmaceutical distributors such as McKesson, Cardinal Health, and Alliance Healthcare to ensure global reach, especially for shipments to hospitals, specialty pharmacies, and clinics.

The distribution chain emphasizes cold chain logistics, quality assurance, and regulatory compliance, especially in regions like the U.S. and Europe, where strict manufacturing and distribution standards exist.

Supply Chain Challenges and Risks

The supply of CAMZYOS hinges on the stability of raw material and API suppliers, which face risks including:

• Regulatory delays or compliance issues in supplier countries.
• Manufacturing bottlenecks due to process complexity or capacity limitations.
• Global supply chain disruptions, including geopolitical tensions, pandemics, or raw material shortages.
• Scaling challenges during transitioning from clinical to commercial manufacturing.

Bristol-Myers Squibb mitigates these risks through diversified supplier relationships and stringent quality requirements. That said, dependency on select CMOs and chemical suppliers accentuates supply risk profile, necessitating continuous oversight and contingency planning.

Regulatory Considerations

Suppliers of API and excipients must adhere to strict Good Manufacturing Practices (GMP) and regulatory standards mandated by agencies such as the FDA and EMA. BMS monitors this compliance via auditing and quality assurance programs, ensuring consistent supply and safety.

Furthermore, cross-border supply chains must navigate trade regulations, import-export restrictions, and customs documentation, especially given the complex nature of active ingredient sourcing in regions with differing regulatory environments.

Market Implications and Strategic Outlook

The limited number of specialized suppliers for MAVacamten's API and complex formulation processes mean that supply chain continuity is paramount for market success. Strategic partnerships with CMOs and chemical suppliers enhance manufacturing agility, reduce vulnerabilities, and support global distribution initiatives.

BMS’s investment in manufacturing capacity expansion and supplier diversification can preempt shortages, essential given CAMZYOS’s status as a first-in-class therapy for HCM. As the drug gains approval and expands into additional markets, continuous supply chain evaluation will remain critical.

Key Takeaways

• Core API Suppliers: Bristol-Myers Squibb engages with leading CMOs such as Lonza and Catalent for mavacamten API manufacturing, ensuring high-quality, regulatory-compliant production.
• Raw Material Sourcing: Chemical intermediates and reagents are primarily obtained from reputable providers like Sigma-Aldrich and Alfa Aesar, supporting complex synthesis routes.
• Distribution Network: Global pharmaceutical distributors, including McKesson and Cardinal Health, facilitate CAMZYOS’s delivery with specialized cold chain logistics.
• Supply Risks: Limited supplier diversity, complex manufacturing processes, and geopolitical factors pose risks requiring proactive mitigation.
• Regulatory Compliance: Continuous oversight by BMS ensures supplier adherence to GMP standards, vital for maintaining supply chain integrity and market confidence.

FAQs

1. Who are the primary API suppliers for CAMZYOS?
Bristol-Myers Squibb sources mavacamten’s API mainly through contract manufacturing organizations such as Lonza and Catalent, which specialize in complex chemical synthesis under GMP standards.

2. Are there concerns about supply chain disruptions for CAMZYOS?
Yes. The specialized nature of mavacamten’s manufacturing and reliance on a limited number of high-quality suppliers entail inherent risks. BMS actively manages these through supplier diversification, quality oversight, and capacity expansion.

3. What role do excipient suppliers play in CAMZYOS’s supply chain?
Excipients are sourced from companies like BASF, Evonik, and Jubilant, which provide high-purity formulation components ensuring product stability, efficacy, and regulatory compliance.

4. How does Bristol-Myers Squibb ensure regulatory compliance in manufacturing?
Through stringent supplier qualification procedures, routine audits, adherence to GMP standards, and continuous monitoring of manufacturing processes across all partner facilities.

5. What strategic measures can mitigate supply risks for CAMZYOS?
Diversifying supplier base, increasing manufacturing capacity, establishing regional supply hubs, and maintaining buffer inventory levels are key strategies to safeguard supply continuity.

References

[1] Bristol-Myers Squibb. CAMZYOS (mavacamten) Prescribing Information.
[2] U.S. Food and Drug Administration. Mavacamten Approval Documentation.
[3] Contract Manufacturing Organizations – Lonza, Catalent. Public profiles and service offerings.
[4] Pharmaceutical excipient suppliers: BASF, Evonik, Jubilant Life Sciences. Product catalogs and quality standards.
[5] Global supply chain logistics reports – McKesson, Cardinal Health, and Alliance Healthcare documentation.