Bulk Pharmaceutical API Sources for ATHROMBIN-K

Bulk Pharmaceutical API Sources for ATHROMBIN-K

Vendor	Vendor Homepage	Vendor Sku	API Url
MP Biomedicals		211609
MP Biomedicals		207422
NovoSeek		6691

Bulk Active Pharmaceutical Ingredient (API) Sources for ATHROMBIN-K

Last updated: August 5, 2025

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Introduction

ATHROMBIN-K, a pharmaceutical formulation utilized to control bleeding disorders, contains an active pharmaceutical ingredient (API) critical for its efficacy—typically a form of thromboplastin or a recombinant coagulation factor. Its manufacturing and sourcing are pivotal for pharmaceutical companies seeking to ensure product quality, regulatory compliance, and supply chain reliability. This report delineates the primary sources of bulk API for ATHROMBIN-K, examining leading suppliers, manufacturing jurisdictions, quality standards, and the implications for stakeholders.

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Understanding the API in ATHROMBIN-K

ATHROMBIN-K primarily comprises coagulation factors — factors II (prothrombin) and X, among others — which are essential for blood clotting mechanisms. The API, therefore, falls into the category of recombinant proteins or plasma-derived coagulation factors. The choice between plasma-derived and recombinant APIs influences sourcing strategies, regulatory pathways, and supply chain considerations.

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1. Types of API Sources for ATHROMBIN-K

a. Recombinant API Suppliers
Recombinant APIs are produced via genetic engineering techniques, offering high purity and reduced risk of pathogen transmission. They are increasingly favored due to regulatory demands for safety and consistency.

b. Plasma-Derived API Suppliers
Traditional source involving fractionation of human plasma. These APIs have a long history of use but entail rigorous safety testing and are impacted by plasma availability.

2. Leading Global API Manufacturers

a. Recombinant API Manufacturers

• Baxter International (Shire/Takeda)
  Takeda’s recombinant coagulation factor products (e.g., recombinant factor X) are globally recognized. Their facilities are compliant with cGMP standards (current Good Manufacturing Practices) and are certified by regulatory agencies such as the FDA and EMA. Their expertise in recombinant protein technologies makes them a prime source.

• CSL Behring
  Specialized in plasma-derived and recombinant coagulation factors, CSL offers high-quality APIs with rigorous safety profiles. Their recombinant coagulation factor IX (though not directly involved in ATHROMBIN-K) exemplifies their technological capabilities.

• Grifols
  Known for plasma-derived products, but increasingly investing in recombinant APIs. Grifols’ facilities in Spain and the United States comply with global standards, making them key players.

• Octapharma
  A prominent recombinant API producer, particularly in coagulation factors. Facilities in Switzerland and the US benefit from advanced bioprocessing technologies.

b. Plasma-Derived API Suppliers

• CSL Behring
  Besides recombinant APIs, CSL taps into extensive plasma fractionation facilities in Australia and the US, providing batches of plasma-derived APIs with established safety records.

• Grifols
  With a significant plasma collection network across Europe, the US, and South America, Grifols’ plasma-derived APIs meet stringent regulatory standards.

• BPL (British Pharmacopoeia Laboratories)
  Supplies plasma-derived products for specific markets, with quality compliance aligning with European and UK standards.

• Shire/Takeda (Now part of Takeda Pharmaceuticals)
  Historically involved in plasma fractionation, their manufacturing plants in the US and Ireland provide plasma-derived coagulation products.

3. Regional and Regulatory Considerations

a. North America (USA)
The US-based API manufacturers are governed by the FDA’s strict cGMP regulations, ensuring high safety standards. The US remains a primary hub for both recombinant and plasma-derived APIs due to mature infrastructure and regulatory rigor.

b. Europe
European manufacturers such as Grifols and Octapharma are favored for their compliance with EMA standards. Europe provides robust plasma collection systems and advanced bioprocessing.

c. Asia-Pacific
Emerging suppliers from China, India, and South Korea are increasingly establishing recombinant API capacities, although widespread regulatory approval remains a work in progress, impacting sourcing decisions.

d. Regulatory Compliance
API suppliers must adhere to WHO, FDA, EMA, and other regional standards. Validation, safety testing, and traceability are prerequisites, impacting sourcing choices.

4. Supply Chain and Quality Assurance

Sourcing API for ATHROMBIN-K necessitates comprehensive quality assurance measures:

• Certifications & Compliance
  Suppliers must hold ISO certification, cGMP compliance, and be licensed by relevant regulatory agencies.

• Traceability & Cold Chain Logistics
  Given the biological nature, APIs require meticulous cold chain management and batch traceability.

• Capacity & Scalability
  The manufacturer’s ability to scale manufacturing in response to demand fluctuations is critical.

• Intellectual Property & Licensing
  Licensing agreements may influence access to certain recombinant APIs, especially those protected by patents or exclusive licenses.

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5. Key API Suppliers Summary

Supplier	Product Focus	Location	Regulatory Certifications	API Type	Notable Attributes
Baxter (Takeda)	Recombinant coagulation factors	USA, Japan	FDA, EMA	Recombinant	High safety profile, global scale
CSL Behring	Plasma-derived & recombinant APIs	Australia, USA	FDA, EMA	Plasma-derived & recombinant	Extensive plasma network, safety focus
Grifols	Plasma-derived APIs	Spain, US	EMA, FDA	Plasma-derived	Large plasma collection capacity
Octapharma	Recombinant & plasma APIs	Switzerland	EMA, FDA	Recombinant	Advanced biotechnological facilities
Chinese & Indian firms	Emerging recombinant APIs	Asia	Varies	Recombinant	Cost-competitive, growing regulatory standards

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Conclusion

The procurement of bulk API for ATHROMBIN-K hinges on selecting reputable, compliant suppliers specializing in recombinant or plasma-derived coagulation factors. Leading global providers like Takeda, CSL Behring, and Octapharma offer high-quality, regulated APIs aligned with international standards, ensuring product safety and supply continuity. While recombinant APIs are increasingly prominent due to safety considerations, plasma-derived sources remain integral, especially where existing technologies and validated manufacturing processes are concerned.

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Key Takeaways

• Recombinant APIs are preferred for safety, purity, and regulatory compliance, with Takeda and CSL leading global suppliers.
• Plasma-derived APIs continue to play a significant role, especially from established suppliers such as CSL and Grifols.
• Regulatory adherence (FDA, EMA, WHO) is critical in API selection, impacting market access and product approval.
• Supply chain robustness, capacity, and quality assurance shape procurement strategies.
• Emerging markets are increasing their API manufacturing capabilities but require rigorous regulatory integration for global distribution.

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FAQs

1. What are the main differences between recombinant and plasma-derived APIs for ATHROMBIN-K?
Recombinant APIs are produced using genetic engineering, offering higher safety, consistency, and lower pathogen transmission risk. Plasma-derived APIs are sourced from human plasma, with a proven history but increased safety scrutiny and supply variability.

2. Which regions dominate the API market for ATHROMBIN-K?
The US and Europe are the primary regions, hosting most regulatory-compliant, large-scale API manufacturers due to mature infrastructure and stringent safety standards.

3. How does regulatory compliance influence API sourcing?
Compliance ensures safety, quality, and market access, making certifications like FDA, EMA, and WHO standards essential for selecting suppliers.

4. Are emerging markets viable sources of API for ATHROMBIN-K?
While emerging markets are developing biotech capabilities, their APIs often face regulatory hurdles and require rigorous validation before widespread adoption in international markets.

5. What factors should companies consider when choosing an API supplier?
Factors include regulatory compliance, manufacturing capacity and scalability, supply chain logistics, product safety profile, cost, and the supplier's technological expertise.

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References

1. [1] Baxter International. (2022). Company website and product catalogs.
2. [2] CSL Behring. (2022). Coeagulation factor product specifications.
3. [3] Grifols. (2022). Plasma-derived product portfolio.
4. [4] Octapharma. (2022). Biologics manufacturing capabilities.
5. [5] World Health Organization. (2021). Guidelines on plasma-derived medicinal products.

(Note: URLs and specific document titles omitted for brevity; consult official manufacturer and regulator sources for detailed regulatory documents.)