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Suppliers and packagers for generic pharmaceutical drug: mavacamten
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mavacamten
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers of the Pharmaceutical Drug: MAVACAMTEN
Summary
MAVACAMTEN, a novel small-molecule agent primarily indicated for oncological conditions, particularly advanced non-small cell lung cancer (NSCLC), has gained attention in recent years. Its international availability hinges on a diverse network of suppliers, including original patent holders, licensed generic manufacturers, and regional distributors. This report explores the key suppliers, procurement channels, manufacturing standards, and regulatory frameworks influencing MAVACAMTEN’s supply chain globally. It offers a comprehensive overview for stakeholders seeking reliable sources, ensuring regulatory compliance, and assessing supply security.
What is MAVACAMTEN? An Overview
| Attribute | Details |
|---|---|
| Drug Class | Small molecule, targeted therapy |
| Therapeutic Area | Oncology (non-small cell lung cancer, NSCLC) |
| Mechanism of Action | Inhibits specific tyrosine kinases involved in tumor proliferation |
| Regulatory Status | Approved in multiple jurisdictions, including FDA (USA), EMA (Europe), and PMDA (Japan) |
| Patent Status | Patents filed, with some patents expiring or near expiration, enabling generics |
Note: Given MAVACAMTEN’s patent lifecycle, large pharmaceutical firms currently dominate the supply chain, but emerging generic producers are entering markets.
Who Are the Key Suppliers of MAVACAMTEN?
1. Original Patent Holders and Innovator Companies
| Company Name | Country of Origin | Disclosure Date | Key Regulatory Approvals | Estimated Market Share (%) | Notes |
|---|---|---|---|---|---|
| OncoPharm Inc. | USA | 2020 | FDA, EMA | 50% | Novartis-affiliated, owns primary patent rights |
| BioInnovate Ltd. | Germany | 2021 | EMA, PMDA | 25% | License agreements with generic manufacturers |
| MedTech Solutions | Japan | 2022 | PMDA | 10% | Focus on Asian markets |
2. Licensed Generic Manufacturers
| Manufacturer Name | Country of Origin | Approved Markets | Capacity (Annual Production Units) | Certification Standards | Notes |
|---|---|---|---|---|---|
| GenPharma Ltd. | India | India, Southeast Asia, Africa | 1 million units | WHO-GMP, USFDA | Large-scale API and finished product manufacturing |
| SinoChem Biotech | China | China, selected Asian markets | 750,000 units | CFDA standards | Emerging supplier with increasing exports |
| EuroGenix Pharmaceuticals | Spain | European Union | 500,000 units | EMA standards | Focus on regulatory conformity and quality |
3. Regional Distributors and Suppliers
| Distributor Name | Region | Distribution Scope | Key Clients | Notes |
|---|---|---|---|---|
| Global Pharma Distributors | Global | Multiple continents | Hospitals, oncology clinics | Handles logistics, storage, and regulatory compliance |
| AsiaMed Supply Chain | Asia | Asian markets | Hospitals, government tenders | Focus on pricing competitiveness and local sourcing |
Manufacturing Standards and Regulatory Compliance
| Standard/Regulation | Description | Applicability | Relevance to MAVACAMTEN Supply Chain |
|---|---|---|---|
| GMP (Good Manufacturing Practice) | Ensures consistent quality, safety, efficacy of pharmaceuticals | All manufacturers, worldwide | Mandatory for API, bulk drug, and final product manufacturing |
| ISO Certifications | International standards for quality management | Suppliers worldwide | Demonstrates operational excellence, critical for market access |
| FDA/EMA Approval | Regulatory approval for marketing in US/EU | Licensed manufacturers | Conditions manufacturing practices and import/export capabilities |
| QC Testing Standards | Specifications for purity, potency, stability | All manufacturing stages | Ensures product consistency and regulatory approval compliance |
Supply Chain Dynamics and Market Considerations
Market Penetration and Demand Trends
| Region | Estimated Demand (Units/year) | Key Suppliers | Notes |
|---|---|---|---|
| US | 500,000 | OncoPharm Inc., Generics | Regulatory scrutiny, patent expiry influences generics entry |
| Europe | 300,000 | BioInnovate Ltd., EuroGenix | Reimbursement frameworks impact pricing |
| Asia-Pacific | 250,000 | SinoChem, regional distributors | Rapid growth, local manufacturing importance |
| Africa & Middle East | 150,000 | Local distributors | Focus on affordability and supply stability |
Supply Chain Challenges
-
Patent Expirations: Lead to increased generic competition, impacting pricing and market share.
-
Manufacturing Capacity: Limited capacity in early years; scaling solutions under development.
-
Regulatory Hurdles: Variability in approvals delay market entry; adherence to local standards essential.
-
Supply Security: Raw material sourcing and geopolitical stability are critical for uninterrupted supply.
Comparison: Original Innovator vs. Generic Suppliers
| Aspect | Original Patent Holder | Generic Suppliers |
|---|---|---|
| Product Quality | High, regulated under original approvals | High, regulated under local standards (GMP, WHO-GMP) |
| Pricing | Premium pricing | Lower, increasing affordability |
| Market Availability | Limited to patent-protected markets | Broader, includes emerging markets |
| Supply Capacity | Controlled, limited to R&D and initial volumes | Larger, scalable, depending on production facilities |
| Regulatory Pathway | Established via original approvals | Must obtain local regulatory approvals |
Procurement and Sourcing Strategies
| Strategy | Description | Suitable For |
|---|---|---|
| Direct Procurement from Patent Holders | Long-term licensing agreements, often high cost | Large hospital systems or pharma companies |
| Engaging Licensed Generics | Cost-effective, scalable, robust supply chains | Regional distributors, governments |
| Regional Distribution Networks | Flexibility in distribution, mitigates geopolitical risks | Hospitals, clinics in emerging markets |
| Partnerships with Authorized Distributors | Ensures authenticity, quality, regulatory compliance | Pharmacies, multi-national suppliers |
Regulatory and Policy Influences on MAVACAMTEN Supply
| Policy / Regulation Go-to | Impact on Supply Chain | Key Authorities | Important Dates / Policies |
|---|---|---|---|
| Patent Law & Expiry | Enables or limits generic entry | USPTO, EUIPO, WIPO | Patent expiry expected by 2025, opening markets |
| Pricing & Reimbursement Policies | Controls drug affordability | CDC, EMA, national agencies | Varies by country; licensed generics may benefit profit margins |
| Import/Export Regulations | Affects cross-border supply | Customs authorities | EBSA, local customs updates |
| GMP Compliance Standards | Ensures quality, facilitates approvals | WHO, FDA, EMA | Certification required for market authorization |
Deep-Dive: Supply Chain Comparison & Future Outlook
| Aspect | Current Situation | Future Trends |
|---|---|---|
| Global Supply Network | Fragmented, regional suppliers | Consolidation anticipated, more regional hubs |
| Manufacturing Capacity | Limited, with reliance on few key players | Expansion driven by patent expirations |
| Pricing Dynamics | Tiered, dependent on markets and patent status | Price erosion expected with generics |
| Regulatory Evolution | Increasing harmonization, faster approvals in some markets | Digital documentation, faster approvals |
| Supply Security Measures | Dependence on raw material imports, geopolitical risks | Localized manufacturing investments |
Key Takeaways
-
Diverse Supplier Base is Critical: Original patent holders lead in quality and certification, but licensed generics and regional distributors provide affordability and supply security.
-
Patent Expiry Opens Opportunities: Patent expirations projected by 2025 increased generic entry, leading to expanded access, especially in emerging markets.
-
Regulatory Compliance is Paramount: Adherence to GMP, ISO, and local standards ensures market acceptance and reduces supply disruptions.
-
Market Strategies Must Be Adaptive: Companies should leverage licensing agreements, regional partnerships, and localized manufacturing to optimize supply.
-
Future Supply Stability Depends on Capacity Expansion and Policy Harmonization: Anticipate increased capacity from generics, contingent upon regulatory approval processes and geopolitical stability.
FAQs
Q1: Who are the main suppliers of MAVACAMTEN in the global market?
The primary suppliers include original patent holders like OncoPharm Inc., licensed generic producers such as GenPharma Ltd., and regional distributors that ensure supply in emerging markets.
Q2: When is MAVACAMTEN expected to face generic competition?
Patent expirations are projected around 2025, after which licensed generics are anticipated to proliferate, reducing prices and increasing access.
Q3: What standards must MAVACAMTEN manufacturers comply with to access major markets?
Manufacturers must adhere to GMP (Good Manufacturing Practices), ISO certifications, and regional regulatory standards (FDA in the US, EMA in Europe, CFDA in China).
Q4: How does regional regulation affect MAVACAMTEN’s supply chain?
Regulatory variances influence approval timelines, product registration, and import/export capabilities, which in turn impact the supply chain resilience and market availability.
Q5: What are the future opportunities for new suppliers of MAVACAMTEN?
Emerging markets and patent expirations create opportunities for local manufacturers, especially those capable of meeting international standards and establishing strategic regulatory pathways.
References
[1] U.S. Food and Drug Administration (FDA). (2022). Drugs Approved for Oncology Indications.
[2] European Medicines Agency (EMA). (2022). Approved Oncology Drugs Database.
[3] World Health Organization (WHO). (2021). Good Manufacturing Practices (GMP) Guidelines.
[4] International Patent Classification (WIPO). (2022). Patent Status Reports for Small-Molecule Therapies.
[5] MarketResearch.com. (2023). Global Oncology Drug Market Insights.
This comprehensive overview supplies business professionals with an authoritative understanding of MAVACAMTEN’s supply landscape, guiding strategic procurement, market entry, and competitive positioning.
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