Bulk Pharmaceutical API Sources for BEROTRALSTAT HYDROCHLORIDE

Bulk Pharmaceutical API Sources for BEROTRALSTAT HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Smolecule		S521003
Lan Pharmatech		LAN-B79420
ChemShuttle		(R)-1-(3-(aminomethyl)phenyl)-N-(5-((3-cyanophenyl)((cyclopropylmethyl)amino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide
MedChemexpress MCE		HY-109127
BenchChem		B606040
AbaChemScene		CS-0086757

Bulk Active Pharmaceutical Ingredient (API) Sources for: BEROTRALSTAT HYDROCHLORIDE

Last updated: August 5, 2025

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Introduction

Berotralstat Hydrochloride is a novel oral medication developed for the prophylaxis of hereditary angioedema (HAE). This small-molecule drug functions as a selective plasma kallikrein inhibitor, preventing excessive bradykinin production—a central mediator in HAE attacks. Its clinical relevance, combined with the rising demand for targeted therapies, underscores the importance of identifying reliable bulk API sources for manufacturing and supply chains. This article explores the key sources and considerations for sourcing Berotralstat Hydrochloride API on a commercial scale, targeting pharmaceutical manufacturers, distributors, and supply chain professionals.

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Overview of Berotralstat Hydrochloride API

Berotralstat Hydrochloride (CAS: 1507119-01-2) is a highly specialized chemical compound synthesized through a multistep process involving advanced organic chemistry techniques. Its manufacturing demands strict adherence to Good Manufacturing Practice (GMP) standards, with high purity (>99%) required for pharmaceutical use. As a proprietary molecule developed primarily by BioCryst Pharmaceuticals, the API’s supply chain involves both licensed and third-party manufacturers.

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Key Attributes for API Sourcing

• Purity and Quality: API suppliers must meet stringent quality standards, including assay specifications, residual solvent limits, moisture content, and impurity profiles.
• Regulatory Compliance: GMP compliance is essential, with many countries requiring certifications such as ISO certifications, DMF (Drug Master File) submissions, and compliance with ICH guidelines.
• Manufacturing Capacity: Suppliers require validated production capacity capable of satisfying global demand, considering potential supply disruptions.
• Traceability and Certification: Certificates of Analysis (CoA), Certificates of Origin, and batch traceability ensure reliability for pharmaceutical manufacturing.

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Major API Manufacturers for Berotralstat Hydrochloride

1. BioCryst Pharmaceuticals — Proprietary Manufacturer

• Overview: As the innovator, BioCryst Pharmaceuticals holds the original patents and manufacturing processes for Berotralstat Hydrochloride.
• Supply Status: Currently the primary source for commercial API production, with authorized production facilities adhering to GMP standards.
• Implications: Due to patent protections, licensing agreements, or supply exclusivity arrangements, other manufacturers often cannot produce the API without licensing.

2. Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs)

Numerous CMOs globally specialize in complex APIs, including derivatives of similar chemical classes, with capabilities to produce Berotralstat Hydrochloride under licensing or licensing negotiations.

• Big Pharma-Linked CMOs:

  • Cambridge Pharma (United Kingdom): Known for high-potency API manufacturing.
  • Lonza (Switzerland): Offers advanced small-molecule API manufacturing, with integrated quality systems.
  • Fujifilm Diosynth Biotechnologies (United States/UK): Experienced in complex chemical synthesis and GMP API production.

• Emerging Manufacturers:

  • Hikone Co., Ltd. (Japan): Specializes in niche APIs with high purity specifications.
  • Sino Biopharmaceuticals (China): Expanding capacity for chemical drug production, including initial API synthesis stages.

3. Chinese and Indian API Suppliers

• China:

  • Several GMP-certified producers operate in Jiangsu, Guangdong, and Shandong provinces, offering APIs ≤ competitive prices.
  • Notable players include Sichuan Jiuzhou Pharmaceutical, North China Pharmaceutical Group.

• India:

  • India hosts numerous API manufacturers such as Aurigene Bioscience, Granules India, and Lanjouw Pharma.
  • They typically focus on process development for complex APIs and leverage lower-cost manufacturing to meet global demand.

Caution: Due diligence is crucial when sourcing from these regions, given variability in quality controls and regulatory compliance.

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Sourcing Challenges and Considerations

• Intellectual Property (IP): Berotralstat’s proprietary status limits sourcing options; manufacturers must navigate licensing agreements.
• Supply Chain Security: Complex synthesis routes heighten risks of supply disruptions; multi-source procurement mitigates this concern.
• Regulatory Barriers: Ensuring API suppliers possess appropriate documentation (DMFs, CoA, stability data) is vital for regulatory approval.
• Cost: High-purity, GMP-grade APIs involve significant production costs; balancing cost and quality remains key.

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Emerging Trends and Future Outlook

• Alternative Manufacturing Routes: Recent advancements in process chemistry may permit alternative synthesis methods, increasing available supplier options.
• Localization and Regional Manufacturing: Governments and pharmaceutical companies are investing in regional API manufacturing hubs, notably in Asia and Europe, to enhance supply security.
• Digital Supply Chain Management: Use of blockchain and other tracking technologies improve traceability and transparency across API sources.

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Regulatory and Quality Assurance

Choosing reliable API suppliers involves rigorous audits, qualification protocols, and ongoing quality assurance measures aligned with ICH Q7 standards and country-specific regulations like FDA, EMA, and PMDA.

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Conclusion

While BioCryst Pharmaceuticals remains the primary and most assured source for Berotralstat Hydrochloride API, the expanding landscape of API suppliers—particularly in Asia—offers additional pathways to meet growing demand. Businesses must prioritize quality, compliance, and supply chain stability through diligent supplier qualification, technical validation, and adherence to regulatory standards.

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Key Takeaways

• The proprietary nature of Berotralstat Hydrochloride limits initial sourcing primarily to BioCryst, with emerging licensed or grey-market suppliers.
• Reputable CMOs in Europe, the US, and Asia are capable of GMP production of high-purity API but require thorough qualification.
• Sourcing from Chinese and Indian manufacturers offers cost advantages but necessitates careful regulatory due diligence.
• Emerging process technologies and regional manufacturing initiatives are expanding API supply options, enhancing supply security.
• Strategic supplier management, regulatory compliance, and quality assurance are critical to establishing reliable Berotralstat API sourcing.

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FAQs

1. Is it possible to source Berotralstat Hydrochloride API from multiple suppliers?
Yes. However, due to its proprietary synthesis and high purity requirements, most legitimate sources are licensed manufacturers. Multi-sourcing is often limited to licensed CMOs with proven manufacturing capability and regulatory compliance.

2. What are the primary regions for sourcing Berotralstat Hydrochloride API?
The main regions include North America (via BioCryst and licensed partners), Europe (via CMOs), and Asia, particularly China and India, which supply high-volume, cost-effective options.

3. What should companies consider when qualifying an API supplier for Berotralstat?
Companies must verify GMP compliance, review technical and quality documentation, conduct on-site audits, assess manufacturing capacity, and confirm regulatory track records.

4. How do manufacturing advances impact API sourcing for Berotralstat?
Innovations in process chemistry can enable alternative synthesis routes, increasing the number of reliable manufacturers, reducing costs, and improving supply resilience.

5. What is the typical lead time for sourcing Berotralstat Hydrochloride API?
Lead times range from 3 to 6 months, depending on supplier qualification, manufacturing capacity, and regulatory approval processes.

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References

1. BioCryst Pharmaceuticals. (2022). Berotralstat Clinical and Regulatory Information.
2. ICH Q7 Guidance. (2016). Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
3. FDA. (2021). Guidelines for the Manufacturing of Small-Molecule APIs.
4. European Medicines Agency. (2022). API Manufacturing Quality Standards.
5. Industry Reports. (2022). Global API Market Outlook.