Bulk Pharmaceutical API Sources for DOPTELET

Bulk Pharmaceutical API Sources for DOPTELET

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-13463
ChemShuttle		124899
AbaChemScene		CS-3397
AKos Consulting & Solutions		AKOS027323962
AbovChem LLC		HY-13463
BOC Sciences		570406-98-3
Alfa Chemistry		570406-98-3

Bulk Active Pharmaceutical Ingredient (API) Sources for Doptelet (Avatrombopag)

Last updated: July 29, 2025

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Introduction

Doptelet (brand name for avatrombopag) is an oral thrombopoietin receptor agonist approved primarily for the treatment of thrombocytopenia in adult patients with chronic liver disease or thrombocytopenia secondary to chemotherapy. As a novel therapeutic agent, the quality, sourcing, and regulation of its Active Pharmaceutical Ingredient (API) are crucial for manufacturing, compliance, and market accessibility. This analysis explores the global landscape of API suppliers for avatrombopag, examining supply chains, manufacturing footprints, and strategic considerations pertinent to pharmaceutical companies and stakeholders.

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Overview of Avatrombopag API Manufacturing

Avatrombopag's synthesis involves complex organic chemistry processes, requiring specialized manufacturing capabilities. The API manufacturing process encompasses multiple steps—starting from core chemical synthesis, purification, and quality control—to ensure compliance with Good Manufacturing Practices (GMP). The overarching goal for API suppliers is to deliver high-purity, bioequivalent, and reproducible batches compatible with regulatory standards across global markets.

Global API Suppliers for Doptelet:

1. Core Manufacturer - Responsible for API Production

The primary API supplier for Doptelet, as of current market intelligence, is the original innovator or licensed manufacturing partner responsible for GMP-compliant API production. This manufacturer's identity is often protected under confidentiality agreements, but in the case of avatrombopag, global pharmaceutical sources suggest an established presence in China, with contract manufacturing organizations (CMOs) operating under licensing agreements.

2. Regional API Suppliers

• Chinese CMO Industry:
  China dominates global pharmaceutical manufacturing, hosting several GMP-certified facilities capable of producing complex APIs like avatrombopag. Notable organizations include Zhejiang Hisun Pharmaceutical Co., Ltd. and Zhejiang Huahai Pharmaceutical Co., Ltd., which possess extensive experience in active ingredient synthesis and export.

• Indian API Manufacturers:
  India's vibrant API manufacturing sector features companies such as Divi's Laboratories and Biocon, which supply a broad range of APIs, often under stringent quality standards aligned with international regulations. While specific verification on avatrombopag is limited, these organizations have the capacity to scale production if authorized.

• Other Asian Manufacturers:
  Singapore and South Korea host API producers with advanced facilities capable of delivering high-quality avatrombopag. These manufacturers adhere to strict regulatory standards, including FDA and EMA certifications.

3. Contract Manufacturing and Licensing Agreements

Doptelet's API sourcing often involves licensing agreements between originator companies and third-party manufacturers. These arrangements facilitate scalable supply chains, reduce costs, and mitigate risks associated with single-source dependency.

Regulatory Considerations and Quality Standards

API suppliers must comply with global GMP standards, validated manufacturing processes, and rigorous quality control testing, including assays for purity, residual solvents, heavy metals, and polymorphic consistency. Regulatory agencies such as the FDA, EMA, and PMDA conduct routine audits of API manufacturing sites.

Market Dynamics and Sourcing Strategies

In recent years, pharmaceutical companies have diversified API sourcing to enhance supply security and cost-efficiency, balancing between:

• Vertical integration: controlling API production internally for critical APIs like avatrombopag.
• Global outsourcing: leveraging CROs and CMOs globally to ensure supply flexibility.
• Regional supply chains: mitigating geopolitical and trade risks.

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Emerging Trends and Challenges

• Supply Chain Resilience: The COVID-19 pandemic exposed vulnerabilities in global API supply chains, prompting companies to establish multiple API sources.
• Regulatory Harmonization: Increasing international standards demand that API suppliers maintain compliance with evolving GMP regulations.
• Technological Innovation: Advanced synthesis methods, such as continuous flow chemistry, improve API yields and purity, attractive features for sourcing avatrombopag.

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Conclusion

The landscape of bulk API sources for Doptelet underscores a reliance on a limited but diverse set of manufacturers primarily based in China and India, supplemented by regulatory-compliant suppliers across Asia. Ensuring stability in the API supply chain necessitates strategic supplier diversification, rigorous quality oversight, and adherence to international Good Manufacturing Practices.

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Key Takeaways

• Primary API sourcing for Doptelet is heavily reliant on Chinese and Indian GMP-certified suppliers, supported by regional manufacturing hubs around Asia.
• Regulatory compliance and quality control are essential for maintaining API integrity, which directly impacts drug safety and efficacy.
• Diversifying API sources mitigates supply chain disruptions, especially amid geopolitical and global health challenges.
• Innovations in synthesis and manufacturing methods enhance API quality, yield, and scalability.
• Long-term partnering with trusted CMO vendors and establishing multiple supply channels are critical strategies for sustained API availability.

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FAQs

1. Who are the main API manufacturers for avatrombopag (Doptelet)?
The primary API manufacturer for avatrombopag is likely a GMP-certified organization based in China, such as Zhejiang Hisun Pharmaceutical, operating under licensing agreements with the brand owner. Exact details are often confidential, but these companies possess advanced chemical synthesis capabilities.

2. How does API sourcing impact drug pricing and availability?
Sourcing from regional high-volume manufacturers reduces costs, but dependency on limited suppliers can cause supply constraints. Diversification enhances availability and stabilizes pricing, ensuring uninterrupted supply for market demands.

3. What are regulations governing API manufacturing for avatrombopag?
Manufacturers must comply with GMP standards set by agencies like the FDA, EMA, and PMDA. Regular audits ensure process integrity, purity, and safety, which are mandatory for approval and commercialization.

4. Are there risks associated with API sourcing in China or India?
Yes. Potential risks include regulatory divergence, geopolitical tensions, quality control lapses, and supply chain disruptions. Companies mitigate these by establishing quality agreements, conducting due diligence, and diversifying sources.

5. What technological advancements are influencing API manufacturing for thrombopoietin receptor agonists?
Innovations such as continuous flow chemistry, process automation, and real-time quality monitoring have improved the efficiency, purity, and scalability of APIs like avatrombopag, benefiting supply reliability and regulatory compliance.

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References

[1] U.S. Food and Drug Administration (FDA). "Drug Approval Packages." FDA.gov, 2023.
[2] European Medicines Agency (EMA). "API Manufacturing Standards." EMA.europa.eu, 2023.
[3] Market Intelligence Reports. “Global API Market Analysis,” PharmaTech Reports, 2022.
[4] Industry sources and company disclosures. "API Manufacturers Directory," Pharma Industry Reports, 2023.