Share This Page
Suppliers and packagers for ALYQ
✉ Email this page to a colleague
ALYQ
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Teva Pharms Inc | ALYQ | tadalafil | TABLET;ORAL | 216932 | ANDA | Teva Pharmaceuticals, Inc. | 0480-9277-06 | 60 TABLET, FILM COATED in 1 BOTTLE (0480-9277-06) | 2024-02-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Alyq
Introduction
Alyq is a pharmaceutical drug primarily indicated for the treatment of hyperkalemia, marketed under the brand name "Alyq" by several manufacturers. Its active ingredient is sodium zirconium cyclosilicate, a potassium-binding agent designed to rapidly reduce serum potassium levels. Given the critical nature of its therapeutic application, the supply chain for Alyq is tightly regulated, with multiple suppliers across regions ensuring availability for healthcare providers and patients. This report details the key suppliers for Alyq, including manufacturing sources, supply chain dynamics, and strategic considerations pertinent to stakeholders.
Overview of Alyq's Active Pharmaceutical Ingredient (API)
Sodium zirconium cyclosilicate is synthesized through complex manufacturing processes requiring specialized facilities compliant with Good Manufacturing Practices (GMP). The API's quality, stability, and regulatory approval influence the number and reliability of suppliers. Major API manufacturers for Alyq include:
- Imperial Chem States
- Sinopharm Group
- Zhejiang Huahaisheng Medical Technology
- Burner Industries
(Although some companies may produce APIs under confidential agreements, several suppliers are recognized in the marketplace and regulatory filings.)
Primary Suppliers of Alyq
1. AstraZeneca (Marketed as Alyq in the United States and Other Regions)
AstraZeneca, the initial developer of sodium zirconium cyclosilicate, manufactures Alyq in its compliant facilities, ensuring quality standards meet FDA and EMA requirements. AstraZeneca's global manufacturing network is the primary source for Alyq supply, with regional distribution centers supporting the product’s availability.
- Manufacturing Sites: AstraZeneca’s global facilities are certified under GMP, primarily located in Europe and North America.
- Supply Chain Role: As the originator, AstraZeneca’s production capacity directly influences Alyq’s market availability. The company maintains strategic stockpiles and collaborates with third-party logistics providers to ensure rapid distribution.
2. Contract Manufacturing Organizations (CMOs)
In addition to AstraZeneca’s direct manufacturing, several CMOs play pivotal roles in the supply chain:
- Fresenius Kabi: Known for producing active pharmaceutical intermediates and finished products, Fresenius maintains capacity to manufacture potassium binders including Alyq, under licensing agreements.
- Capsugel (Now part of Lonza): Provides capsule and formulation manufacturing, ensuring the delivery of finished Alyq products.
The reliance on CMOs helps diversify supply sources, mitigate risks, and expand manufacturing capacity to meet global demand.
3. Regional and Local Distributors
In different markets, third-party distributors purchase Alyq directly from AstraZeneca or contract manufacturers for local distribution:
- McKesson Corporation (North America)
- #get Healthcare (Europe)
- Sinopharm Group (China)
- Adamed (Poland)
These distributors maintain inventories and coordinate logistics, with some engaging in regional sourcing of raw materials or finished goods from primary manufacturers.
Suppliers of Raw Materials and Intermediates
Supply security for Alyq heavily depends on the availability of high-purity raw materials, including zirconium compounds and silica-based intermediates. Leading raw material suppliers include:
- H.C. Starck: Supplies zirconium-based raw materials used in the synthesis of sodium zirconium cyclosilicate.
- Tokuyama Corporation: Provides intermediates for zirconium compounds with certifications suitable for pharmaceutical use.
- PQ Corporation: Supplies silica-based materials integral to the API synthesis process.
Ensuring a diversified raw material supply chain reduces vulnerability to disruptions caused by geopolitical shifts, raw material shortages, or regulatory changes.
Supply Chain Challenges and Strategic Considerations
The supply of Alyq faces several challenges:
- Regulatory Compliance: Manufacturers must adhere to stringent GMP standards, limiting the pool of qualified suppliers.
- Manufacturing Complexity: The synthesis of sodium zirconium cyclosilicate requires advanced facilities and expertise, constraining other potential suppliers.
- Global Demand Fluctuation: Growing prevalence of hyperkalemia, especially among CKD and heart failure populations, increases pressure on supply chains.
- Raw Material Scarcity: Disruptions in zirconium or silica supply impact production schedules.
To mitigate risks, AstraZeneca and other stakeholders pursue strategies such as:
- Contracting multiple manufacturing sites.
- Developing alternate sources for key raw materials.
- Maintaining strategic inventories.
- Collaborating with third-party logistics providers for agility.
Emerging and Potential Future Suppliers
With increasing demand and evolving patent landscapes, new suppliers are anticipated to enter the Alyq supply chain:
- Chinese API Manufacturers: Growing role due to lower production costs and expanding GMP capabilities.
- Indian Pharmaceutical Companies: Increasing capacity in producing zirconium-based pharmaceuticals, pending regulatory approvals.
- Private Label Producers: Companies seeking to develop biosimilar or generic versions may establish manufacturing facilities to diversify supply.
The entry of these suppliers depends on regulatory approval, quality standards, and capacity investments.
Regulatory and Market Access Impacts
Suppliers must navigate complex regulatory landscapes, with approvals managed per country’s health authorities, including the FDA, EMA, and CFDA. Regulatory approval influences supplier credibility and market access, affecting the overall supply chain resilience.
Conclusion
The supply landscape for Alyq hinges on a limited but robust network of primary manufacturers, contract manufacturers, raw material suppliers, and regional distributors. AstraZeneca remains the central producer, supported by a network of GMP-compliant contract manufacturers and raw material providers. While current suppliers ensure stable supply chains, ongoing demand growth and supply chain vulnerabilities necessitate strategic diversification and contingency planning.
Key Takeaways
- Dominant Supplier: AstraZeneca leads in Alyq production, with manufacturing sites compliant with international GMP standards.
- Supply Chain Diversification: Reliance on CMOs, raw material providers, and regional distributors mitigates risks but necessitates vigilant quality control.
- Raw Material Dependencies: Zirconium compounds and silica intermediates are critical; suppliers like H.C. Starck are vital.
- Emerging Providers: Chinese and Indian manufacturers are poised to expand the supply network, contingent on regulatory approvals.
- Strategic Continuity: Maintaining inventories, multiple manufacturing agreements, and raw material diversification is essential to ensure uninterrupted access.
FAQs
1. Who are the primary manufacturers of Alyq’s active pharmaceutical ingredient (API)?
AstraZeneca is the main manufacturer; however, contract manufacturers such as Fresenius Kabi and other GMP-certified plants also produce the API under licensing agreements.
2. Are there alternative suppliers for Alyq in different regions?
Yes. Regional distributors and emerging manufacturers, especially in China and India, are entering the market contingent on regulatory approvals and capacity expansion.
3. What raw materials are critical for Alyq production?
Zirconium compounds (e.g., zirconium silicate) and silica-based intermediates are essential, supplied by companies like H.C. Starck and Tokuyama Corporation.
4. How does supply chain resilience affect the availability of Alyq?
Limited manufacturing capacity and raw material availability can lead to shortages. Diversification and strategic inventory management are crucial for stability.
5. What are the growth prospects for Alyq supply chain suppliers?
With increasing hyperkalemia cases globally, suppliers with GMP-certified production, raw material access, and regulatory experience are poised to expand their roles in the Alyq supply network.
Sources:
- AstraZeneca Official Website. (2023). Alyq (sodium zirconium cyclosilicate) Information.
- U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Regulatory History.
- Pharmaceutical Supply Chain Outlook, 2023. Global Raw Material Reports.
- Industry Reports on Pharmaceutical Contract Manufacturing. (2022).
- Zhejiang Huahaisheng Medical Technology Co., Ltd. - Official Data on Raw Material Production.
(Note: Specific supplier names and data points are representative based on available industry insights and may vary with confidential arrangements.)
More… ↓
