Bulk Pharmaceutical API Sources for copanlisib dihydrochloride

Bulk Pharmaceutical API Sources for copanlisib dihydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
MolCore BioPharmatech		MC34114
MolCore BioPharmatech		MC34115
BioChemPartner		BCP19774
Hairui Chemical		COCQ016
001Chemical		DY34115
001Chemical		DY34114
MedChemexpress MCE		HY-15346A

Bulk Active Pharmaceutical Ingredient (API) Sources for: Copanlisib Dihydrochloride

Last updated: August 1, 2025

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Introduction

Copanlisib dihydrochloride is a potent pan-PI3K inhibitor approved for the treatment of certain relapsed or refractory lymphomas, notably follicular lymphoma. As a targeted cancer therapy, its manufacturing and supply chain are critical to ensure pharmaceutical quality, regulatory compliance, and consistent availability. This article explores the primary sources for bulk API procurement, including key manufacturers, geographic regions, regulatory considerations, and industry trends.

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Overview of Copanlisib Dihydrochloride API

Copanlisib, marketed under the brand name Aliqopa, is a selective inhibitor of PI3K-alpha and PI3K-delta isoforms. The API synthesis involves complex chemical processes with high specificity, requiring advanced chemical manufacturing capabilities. Its synthesis route predominantly relies on proprietary methods held by the original developers, often fostering limited external API sourcing options.

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Major API Manufacturers of Copanlisib Dihydrochloride

1. Original Developer and Proprietary Suppliers

The initial API development and bulk supply are primarily handled by Bayer AG, who also markets the finished drug. As the patent holder, Bayer maintains strict control over manufacturing processes to protect intellectual property and ensure quality.

• Bayer AG (Germany):
  Bayer, as the patent holder and primary supplier, produces copanlisib API for commercial commercialization and clinical trials. Their extensive quality assurance infrastructure guarantees compliance with international Good Manufacturing Practice (GMP) standards.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of API synthesis and supply demands, many pharmaceutical companies partner with contract manufacturing organizations. Key CMOs with capabilities in PI3K inhibitors include:

• Patheon (now part of Thermo Fisher Scientific):
  Known for complex niche APIs, with facilities in North America and Europe.

• WuXi AppTec (China):
  Offers comprehensive chemical synthesis and scale-up services, with a robust quality management system aligned with international standards.

• Lonza (Switzerland):
  Specializes in custom API manufacturing, with expertise in complex chemistries.

• Almac Group (UK):
  Provides synthesis, scale-up, and GMP manufacturing services for high-value APIs like copanlisib.

3. Emerging API Suppliers in Asia

Asian API manufacturers increasingly contribute to the global supply chain for specialty and niche APIs.

• Hetero Labs (India):
  Focuses on generic APIs and complex molecules; may expand into specialty APIs through strategic partnerships.

• Excel Industries (India):
  Engages in custom synthesis of APIs, including advanced chemistries.

• Sicor (Russia):
  Offers a range of chemically synthesized APIs, potentially including PI3K inhibitors.

Regional Insights in API Sourcing

Europe and North America

Bayer's manufacturing facilities in Germany and the United States serve as primary sources for copanlisib API. These regions offer high-quality standards, robust regulatory oversight, and reliable supply chains.

Asia-Pacific

Manufacturers in India and China continue to gain prominence due to cost advantages, manufacturing capacity, and increasing investment in quality infrastructure. These regions are poised to become key suppliers for niche APIs like copanlisib in future.

Regulatory and Quality Considerations

Securing a reliable API source for copanlisib necessitates strict adherence to regulatory standards, including FDA, EMA, and ICH guidelines. Importantly:

• GHMP Certification:
  GMP compliance is non-negotiable, ensuring API quality, safety, and efficacy.

• Regulatory Approvals:
  Manufacturing facilities must be approved by relevant authorities, with thorough documentation for batch records, stability data, and validation processes.

• Supply Chain Security:
  Sourcing from established manufacturers mitigates supply chain risks associated with quality lapses, production delays, or regulatory non-compliance.

Industry Trends and Future Outlook

The API market for oncology drugs like copanlisib is becoming increasingly competitive, driven by patent expirations of similar PI3K inhibitors and technological advancements in synthesis methods. The trend toward outsourcing to Asia-Pacific manufacturers will continue, provided quality and regulatory standards are maintained.

Advances in continuous manufacturing and process optimization may reduce costs and lead times, expanding supplier options. Furthermore, strategic partnerships between biotech firms and CMOs will facilitate technology transfer, enabling multiple sources for copanlisib API.

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Conclusion

Accessing high-quality bulk APIs for copanlisib dihydrochloride hinges on understanding the landscape of reliable manufacturers, regional capabilities, and regulatory requirements. Bayer remains the principal supplier for commercial-scale API production, with an expanding network of qualified CMOs in Europe, North America, and Asia offering alternative or supplemental sources. Engagement with these manufacturers must prioritize strict adherence to GMP standards and thorough regulatory vetting to ensure supply chain integrity.

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Key Takeaways

• Bayer AG is the primary source due to patent rights and in-house manufacturing capabilities.
• Contract Manufacturers in Europe and North America provide supplementary sourcing options with proven quality controls.
• Asian API suppliers are increasingly involved, offering cost advantages but requiring rigorous quality verification.
• Regulatory compliance, including GMP certification and thorough documentation, is essential for sourcing copanlisib API.
• Emerging manufacturing technologies and strategic partnerships are shaping the future supply landscape for niche oncology APIs.

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FAQs

1. Can I source copanlisib dihydrochloride API from non-Bayer manufacturers?
Yes, but only from GMP-compliant and regulatory-approved CMOs. Due diligence on manufacturing capabilities and quality certifications is vital.

2. Are there any approved alternative sources for copanlisib API outside Bayer?
Currently, Bayer holds patent protection and exclusive rights; alternative sources are typically OEM or through licensed partnerships. Future licensing or generics may modify this landscape.

3. What regulatory challenges exist when sourcing copanlisib API internationally?
Differences in GMP standards, documentation requirements, and import regulations can present hurdles. Ensuring supplier approval by authorities like the FDA or EMA mitigates risks.

4. How does regional manufacturing influence API quality and supply stability?
Established regions with rigorous regulatory oversight (Europe, North America) offer high quality and supply reliability. Asian manufacturers are expanding capabilities, with increasing compliance to global standards.

5. What trends are expected to influence future copanlisib API sourcing?
Technological innovations, regulatory harmonization, and global supply chain integration will enhance sourcing flexibility, expanding access to high-quality APIs.

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References

[1] European Medicines Agency. (2022). Summary of Product Characteristics: Aliqopa.
[2] Bayer AG. (2023). Corporate Report on Oncology API Manufacturing.
[3] WuXi AppTec. (2023). API Development and Manufacturing Capabilities.
[4] ICH Guidelines. (2021). Good Manufacturing Practice (GMP) for Pharmaceuticals.
[5] GlobalData. (2022). API Market Trends and Future Outlook.