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Suppliers and packagers for azacitidine
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azacitidine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 207475 | ANDA | Accord Healthcare Inc. | 16729-306-10 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (16729-306-10) | 2019-01-09 |
| Accord Hlthcare | AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 207475 | ANDA | BluePoint Laboratories | 68001-527-54 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68001-527-54) | 2022-02-15 |
| Actavis Llc | AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 208216 | NDA | BluePoint Laboratories | 68001-313-56 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (68001-313-56) | 2017-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Azacitidine
Executive Summary
Azacitidine, commercialized under the brand name Vidaza among others, is a critical chemotherapeutic agent used primarily to treat myelodysplastic syndromes (MDS), certain leukemias, and related hematological cancers. As a nucleoside metabolic inhibitor, its manufacturing and supply chain are vital for healthcare systems worldwide. This report provides a comprehensive overview of key suppliers, manufacturing scales, regulatory considerations, geopolitical influences, and market dynamics impacting azacitidine availability. Business professionals engaged in pharmaceutical procurement, supply chain management, or investment can leverage this detailed landscape analysis to inform strategic decisions.
What is Azacitidine and Why is Supply Critical?
Azacitidine is an analog of cytidine, categorized as a hypomethylating agent. It plays a pivotal role in disease-modifying therapy, particularly in hematologic malignancies. Since its FDA approval in 2004 (amended with expanded indications over subsequent years), demand has increased, accentuating the importance of reliable supply chains.
The drug is usually administered via subcutaneous injection or intravenous infusion, necessitating stringent manufacturing standards. Supply disruptions can directly impact patient access and incur significant financial repercussions for healthcare providers and manufacturers.
Who Are the Major Suppliers of Azacitidine?
A detailed understanding of suppliers involves examining manufacturing entities, geographic distribution, and regulatory approval statuses. The current landscape features several prominent players, with manufacturing centered primarily in established pharmaceutical hubs.
| Manufacturer | Headquarters | Production Capacity | Key Markets | Regulatory Approvals |
|---|---|---|---|---|
| Celgene (Bristol-Myers Squibb) | US | Extensive, global production facilities | US, Europe, Asia | FDA, EMA, others |
| Dr. Reddy’s Laboratories | India | Large-scale manufacturing | India, US, Europe | FDA, EMA, Health Canada, etc. |
| Mundipharma / MUNDIPHARMA SINGAPORE | Singapore | Regional production | Asia-Pacific, some global markets | EMA, other approvals |
| Sun Pharmaceuticals | India | Significant manufacturing footprint | India, US, Europe | FDA, EMA |
| Teva Pharmaceuticals | Israel | Broad global presence | US, Europe, Middle East | FDA, EMA, other certifications |
| Hospira (a Pfizer subsidiary) | US | Large sterile injectables production | US, global | FDA, EMA |
Emerging and Generic Suppliers
Post-patent expiry and increased local manufacturing capacity have led to a proliferation of generic azacitidine suppliers, particularly in India and China:
- Hetero Labs
- Natco Pharma
- Cipla
- Eris Lifesciences
- Zydus Cadila
These manufacturers often supply biosimilar and generic versions approved across various markets, notably under local regulatory pathways.
Manufacturing and Supply Chain Dynamics
1. Production Process and Challenges
Azacitidine synthesis involves complex nucleoside chemistry, demanding high purity standards and strict quality controls. Anything from raw material supply (cytidine derivatives) to purification and stability influences throughput.
- Key Raw Materials: Cytidine, acetic anhydride, solvents, and specialized catalysts.
- Manufacturing Challenges: Complex synthesis, stability issues, batch consistency, and contamination risk.
2. Supply Chain Vulnerabilities
- Raw Material Availability: Dependency on specific chemical precursors, subject to geopolitical fluctuations.
- Regulatory Approvals: Variations in regional standards can delay approvals or manufacturing licenses.
- Manufacturing Capacity Constraints: Limited facilities capable of high-quality azacitidine production may cause supply shortages.
- Distribution Logistics: Cold chain and sterile conditions must be maintained during transportation, adding complexity.
3. Recent Market Disruptions
The COVID-19 pandemic exposed supply vulnerabilities, with some manufacturers reporting delays due to workforce shortages, raw material access restrictions, or regulatory bottlenecks.
Regulatory and Market Entry Considerations
| Aspect | Details |
|---|---|
| Regulatory Agencies | FDA (US), EMA (EU), PMDA (Japan), other local agencies |
| Approval Pathways | New drug applications, ANDA for generics, biosimilar pathways |
| Manufacturing Standards | cGMP compliance essential for all suppliers |
| Market Trends | Growing demand for affordable generics, biosimilars expansion |
Approval processes involve comprehensive data submissions on efficacy, purity, stability, and manufacturing controls. Suppliers often seek multiple regulatory approvals to diversify market exposure.
Geopolitical and Economic Influences on Supply
1. Patent Status & Market Competition
Azacitidine’s patent has expired in multiple jurisdictions, enabling the rise of generics. However, patents in key markets like the U.S. (expired in 2020) still influence supply rights and licensing.
2. Geographical Concentration of Production
Most manufacturing facilities are in India, China, and Israel, posing risks of regional disruptions due to political, logistical, or environmental factors.
3. Trade Policies & Tariffs
Trade tensions, tariffs, and export restrictions can hinder timely shipment, especially during global crises.
Comparison of Leading Suppliers
| Parameter | Celgene / BMS | Dr. Reddy’s | Sun Pharma | Teva | Generic Suppliers (India/China) |
|---|---|---|---|---|---|
| Market Share (Estimated) | ~40% global footprint | Large, significant in India | Moderate in India, expanding globally | Significant in US, Europe | Rapidly growing |
| Production Capacity | Very high | High | High | High | Varied, generally smaller |
| Pricing Strategy | Premium for branded | Cost-effective generics | Affordable generics | Cost-effective generics | Low-cost, high-volume |
| Regulatory Footprint | Widely approved | Fully approved in key markets | Multiple approvals | Multiple approvals | Approvals in local markets |
Market Outlook and Future Developments
- Increased Access via Generics & Biosimilars: As patents expire, expect increased market penetration of biosimilar azacitidine, reducing costs.
- Supply Chain Resilience Initiatives: Companies are investing in dual sourcing, manufacturing diversification, and regional facilities.
- Regulatory Accelerations: Fast-track pathways and emergency use authorizations can influence availability.
Key Policies Affecting Supply
| Policy | Impact | Source / Date |
|---|---|---|
| Patent Expiry (US, EU) | Allows generic manufacturing, increasing competition | US Patent Office, 2020 |
| GMP Regulations (FDA, EMA) | Enforces manufacturing quality, constrains new suppliers | FDA Guidance (2022), EMA (2023) |
| Trade & Tariff Policies | Affect raw material imports and export flows | US-China Trade Deal (2021), WTO |
| Pandemic Response Measures | Disrupt manufacturing and logistics | WHO, 2020-2022 |
FAQs
1. Who are the dominant azacitidine suppliers in the global market?
The dominant suppliers include BMS (via Celgene), Dr. Reddy’s Laboratories, Sun Pharma, and Teva. These entities possess manufacturing authorization approvals in multiple jurisdictions, contributing significantly to global supply.
2. What factors influence the stability of azacitidine supply?
Supply stability depends on raw material availability, manufacturing capacity, regulatory approvals, geopolitical stability, and distribution logistics.
3. Are there regional differences in azacitidine production?
Yes. Manufacturing is concentrated primarily in India, Israel, and the US, influenced by local regulations, cost structures, and raw material access.
4. How do patent expirations impact the azacitidine market?
Patent lapses introduce more generic manufacturers, increasing supply and reducing costs but potentially leading to supply fragmentation and quality variability.
5. What are the key quality standards expected from azacitidine suppliers?
Suppliers must comply with cGMP standards, ensuring high-purity, batch-to-batch consistency, stability, and proper sterile manufacturing environments.
Key Takeaways
- The global azacitidine supply chain is characterized by a mix of branded, generic, and biosimilar manufacturers, with notable regional disparities.
- Supply security hinges on raw material availability, manufacturing capacity, and regulatory compliance.
- Increased generic and biosimilar entry post-patent expiration will likely lower prices and enhance patient access.
- Supply chain resilience strategies include diversification of manufacturing sites, raw material sourcing, and adherence to stringent quality standards.
- Policymakers and stakeholders must monitor geopolitical developments and regulations to mitigate risks of disruption.
References
- FDA Drug Approvals: FDA Vidaza Approval
- Patent and Market Data: United States Patent Office
- Industry Reports: IQVIA, “The Global Hematology Market,” 2022.
- Regulatory Compliance: EMA Guidelines on Good Manufacturing Practice, 2023.
- Trade Policies: WTO Trade Policy Reviews, 2022.
This report equips business leaders and procurement specialists with a comprehensive understanding of the azacitidine supply environment, enabling strategic planning and risk mitigation.
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