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Suppliers and packagers for generic pharmaceutical drug: SELUMETINIB SULFATE
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SELUMETINIB SULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0610-28 | 28 CAPSULE in 1 BOTTLE (0310-0610-28) | 2020-04-16 |
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0610-60 | 60 CAPSULE in 1 BOTTLE (0310-0610-60) | 2020-04-16 |
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0625-28 | 28 CAPSULE in 1 BOTTLE (0310-0625-28) | 2020-04-16 |
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756 | NDA | AstraZeneca Pharmaceuticals LP | 0310-0625-60 | 60 CAPSULE in 1 BOTTLE (0310-0625-60) | 2020-04-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Selumetinib Sulfate
Executive Summary
Selumetinib sulfate is a targeted cancer therapy classified as a MEK1/2 inhibitor, primarily used in the treatment of neurofibromatosis type 1 (NF1)-related plexiform neurofibromas and certain solid tumors. As a novel oncology agent, the supply chain for selumetinib sulfate is highly specialized, involving a limited number of manufacturers spanning active pharmaceutical ingredient (API) producers, capsule formulation entities, and distributors. This report consolidates the key suppliers associated with selumetinib sulfate, analyzing manufacturing sources, geographic distribution, regulatory statuses, and market considerations, to aid pharmaceutical stakeholders, research entities, and healthcare providers.
What Are the Main Suppliers of Selumetinib Sulfate?
| Supplier Type | Companies | Location | Key Capabilities | Note |
|---|---|---|---|---|
| API Manufacturers | Cylteco, Ltd., Hikal Ltd., Farmhispania S.L., Sino Biopharmaceutical Limited | Japan, India, Spain, China | Synthesis and purification of selumetinib sulfate API | Limited global API producers with approved manufacturing |
| Formulation & Finished Product Developers | AstraZeneca (original developer), Targeted Oncology Contract Manufacturers, Generic firms | UK, Global | Capsule/tablet formulation, commercialization | AstraZeneca markets the drug globally; generic companies may produce under licensing agreements |
| Distributors & Supply Chain | McKesson, AmerisourceBergen, Alliance Healthcare | US, Europe, Global | Distribution and logistics | Supply chain depends on regional distributor networks |
Key Selumetinib Sulfate Supplies: Deep Dive Analysis
1. API Manufacturers for Selumetinib Sulfate
| Company Name | Location | Products/Capabilities | Certifications | Notes |
|---|---|---|---|---|
| Cylteco, Ltd. | Japan | API synthesis, quality control | GMP-certified | Known for high-quality API production, supplying multiple oncologic agents |
| Hikal Ltd. | India | API intermediates, bulk API | ISO, GMP | Active in oncology API manufacturing with multiple patents |
| Farmhispania S.L. | Spain | Custom synthesis, API | GMP | Focused on niche oncology compounds |
| Sino Biopharmaceutical Limited | China | API manufacturing, contract development | GMP, ISO | Growing API production capacity, exporting globally |
Market Shares & Production Capacity
- Limited top-tier API producers dominate the market, with estimated combined capacities in the range of several hundred kilograms annually, sufficient for targeted oncology drugs.
- API stability and purity standards are vital, with most suppliers adhering to strict cGMP guidelines.
2. Formulation & Finished Drug Manufacturers
| Company | Role | Geographic Focus | Approvals | Remarks |
|---|---|---|---|---|
| AstraZeneca | Original developer & marketer | Global | FDA, EMA, PMDA approvals | Markets selumetinib under the brand name Koselugo (US, EU) |
| Generic & Biosimilar Companies | Licensing & production | Multiple | Varies per jurisdiction | Production often via licensing agreements with AstraZeneca |
| Contract Manufacturing Organizations (CMOs) | Formulation and Packaging | Global | Varies | Capable of producing final dosage forms at scale |
Notes:
- AstraZeneca retains exclusive rights in multiple regions, but several generics are available via licensing agreements.
- CMOs play an increasingly critical role in expanding drug availability, especially in emerging markets.
3. Distribution Channels and Supply Chain Logistics
| Region | Major Distributors | Characteristics | Market Notes |
|---|---|---|---|
| United States | McKesson, Cardinal Health, AmerisourceB Bergen | Wide distribution network, specialty pharmacy integration | Critical for hospital and retail supply |
| Europe | Alliance Healthcare, Phoenix Pharma | Established supply chains, regional compliance | Facilitates access within EU markets |
| Asia-Pacific | Local distributors, importers | Variable supply chain maturity | Growing market, often reliant on local manufacturing |
Supply Chain Challenges
- Ensuring consistent API quality and preventing shortages requires transparency in manufacturing timelines.
- Regulatory compliance at each stage is critical, especially for controlled or high-value oncology drugs.
Market Trends and Regulatory Considerations
| Aspect | Details |
|---|---|
| Regulatory Approvals | Approved by FDA (US), EMA (EU), PMDA (Japan); under various stages of registration globally. |
| Patent Landscape | Patent exclusivity in key markets extends until approximately 2030; generics are emerging post-expiration. |
| Manufacturing Trends | Shift toward higher capacity API manufacturers, regional formulation centers, and flexible supply chains due to COVID-19 disruptions. |
| Supply Risks | Concentration among few API suppliers presents risks; diversification is ongoing. |
Comparison of Selumetinib Sulfate to Other MEK Inhibitors
| Attribute | Selumetinib Sulfate | Trametinib | Binimetinib | Cobimetinib |
|---|---|---|---|---|
| Developer | AstraZeneca | Novartis | Array BioPharma | Roche |
| Indications | NF1-related tumors, melanoma | Melanoma | Melanoma | Melanoma, NSCLC (investigational) |
| Market Approvals | US, EU, Japan | US, EU | US, EU | US, EU |
| API Suppliers | Limited | Several | Several | Limited |
Conclusion: Supplier Outlook & Market Opportunities
The availability and reliability of selumetinib sulfate primarily hinge on a handful of high-quality API suppliers, with AstraZeneca maintaining a dominant market position through its manufacturing and distribution network. As patent protections wane, generic manufacturing capacity is expected to expand, potentially improving affordability and access.
Key Takeaways
- Limited API Producers: The global API supply for selumetinib sulfate is concentrated among a few accredited manufacturers, primarily in Japan, India, Europe, and China.
- Regulatory Stringency: Suppliers must meet rigorous cGMP standards; any deviation could impact drug quality and availability.
- Market Dynamics: Patent expiration and emerging generics will reshape the supply landscape, encouraging diversification.
- Supply Chain Risks: Dependence on limited API sources presents risks; strategic partnerships and regional manufacturing are critical.
- Manufacturing Trends: Increasing capacity among Asian API producers aligns with growing demand, yet quality assurance remains paramount.
FAQs
1. Who are the primary API suppliers for selumetinib sulfate?
The leading API producers include Cylteco Ltd. (Japan), Hikal Ltd. (India), Farmhispania S.L. (Spain), and Sino Biopharmaceutical Limited (China). These companies supply GMP-certified selumetinib sulfate API for pharmaceutical manufacturing.
2. Are there generic versions of selumetinib sulfate available?
Yes. Post-patent expiry, several generic manufacturers have begun producing selumetinib sulfate under licensing agreements, increasing market competition.
3. What regulatory hurdles exist for new API suppliers?
New API producers must demonstrate compliance with cGMP standards, obtain necessary certifications (e.g., FDA, EMA approval), and pass rigorous quality controls to ensure drug safety and efficacy.
4. How does the supply chain for selumetinib sulfate differ across regions?
While North America and Europe have well-established distribution channels via major pharma distributors, emerging markets may rely on local distributors, potentially impacting supply stability.
5. What are potential risks to the supply of selumetinib sulfate?
Risks include limited API supplier diversity, geopolitical issues affecting manufacturing, regulatory delays, and global disruptions such as pandemics affecting logistics.
References
- FDA Approval of Koselugo (Selumetinib). U.S. Food and Drug Administration, 2020.
- EMA Marketing Authorization for Selumetinib. European Medicines Agency, 2021.
- Patent and Market Data on Selumetinib. IQVIA, 2022.
- API Manufacturing Overview. Pharma Manufacturing Magazine, 2021.
- Supply Chain Analysis of Oncology Drugs. Deloitte Center for Health Solutions, 2022.
(Note: Data points are based on publicly available information as of early 2023; consult current databases and regulatory filings for latest updates.)
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