Bulk Pharmaceutical API Sources for CIDA-STAT

Bulk Pharmaceutical API Sources for CIDA-STAT

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		9552081
ISpharm		I06-2074
ChemMol		49411785
AKos Consulting & Solutions		AKOS015896303
AK Scientific, Inc. (AKSCI)		M166
Chembase.cn		132286

Bulk Active Pharmaceutical Ingredient (API) Sources for CIDA-STAT

Last updated: July 27, 2025

Introduction

CIDA-STAT (also known as Cidastat or Cidastatin) is a potent synthetic inhibitor targeting specific signaling pathways involved in inflammation and cancer. Its development hinges on sourcing high-quality Active Pharmaceutical Ingredients (APIs) from reliable bulk manufacturers to ensure efficacy, safety, and regulatory compliance. This comprehensive analysis explores available API sources for CIDA-STAT, addressing sourcing strategies, manufacturing options, and key factors influencing supplier selection.

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Understanding CIDA-STAT and Its API Requirements

CIDA-STAT is a small-molecule therapeutic compound, often categorized as a kinase inhibitor. Its synthesis involves complex processes demanding stringent quality standards to meet Good Manufacturing Practice (GMP) guidelines. The API's crucial attributes include high purity (typically >98%), chemical stability, consistency in batch production, and comprehensive documentation to satisfy regulatory authorities like the FDA or EMA.

Given its nature, sourcing APIs for CIDA-STAT requires engagement with specialized chemical manufacturers experienced in synthesizing kinase inhibitors or structurally similar molecules. These API sources must also adhere to batch-to-batch reproducibility, document their quality assurance processes, and provide sufficient traceability.

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Global API Manufacturers for CIDA-STAT

The API market for molecules like CIDA-STAT is segmented across several key regions: North America, Europe, and Asia. Each offers unique advantages regarding manufacturing capacity, cost, and regulatory familiarity.

1. North American API Suppliers

• BASF Corporation
  A major global player with extensive capabilities in custom API synthesis. Their facilities are cGMP-compliant, offering high purity APIs with comprehensive documentation. BASF specializes in complex molecules, including kinase inhibitors, making them suitable for CIDA-STAT supply.

• Amneal Pharmaceuticals
  Known for scalable API manufacturing, Amneal offers custom synthesis and supply chain reliability. Their facilities are FDA-approved, providing consistent APIs suitable for clinical and commercial stages.

• North American Custom Synthesis Labs
  Several boutique manufacturers offer bespoke synthesis of specialized APIs. They often cater to early-stage development, providing flexibility and rapid turnaround, beneficial for ongoing CIDA-STAT development.

2. European API Suppliers

• Evonik Industries
  With expertise in fine chemicals and active pharmaceuticals, Evonik delivers high-quality APIs and custom synthesis. Their European facilities comply with stringent EU GMP standards, providing assurance for regulatory processes.

• Hovione
  Boasting integrated manufacturing and development services, Hovione specializes in complex APIs, including kinase and enzyme inhibitors. Their focus on quality and innovation makes them an attractive source for CIDA-STAT API.

• Polpharma
  A prominent Eastern European manufacturer capable of large-scale API synthesis. They emphasize cost-effective production while maintaining high-quality standards.

3. Asian API Manufacturers

• Shanghai Xinyuan Pharmaceutical Co., Ltd.
  Renowned for cost-effective synthesis of specialty APIs, with GMP certification and extensive experience in kinase inhibitors and related compounds.

• Jiangsu Hengrui Medicine Co.
  A leading Chinese pharmaceutical company, Hengrui offers API manufacturing with robust quality control systems, supplying both domestic and international markets.

• Kangtai Pharmaceutical (India)
  An emerging player offering API synthesis services with competitive pricing, focused on complex molecules like CIDA-STAT.

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Key Considerations in API Sourcing for CIDA-STAT

Regulatory Compliance:
Ensure API manufacturers adhere to internationally recognized GMP standards, with comprehensive documentation including Certificates of Analysis (CoA), stability data, and technical transfer documentation.

Quality Assurance & Control:
High-purity APIs require rigorous QC testing, including identity verification, assay (purity), residual solvent analysis, heavy metals testing, and microbial limits. Confirm the supplier’s capacity to provide batch-specific QA/QC reports.

Supply Chain Security:
Long-term supply agreements are advisable to mitigate risks of shortages, especially vital for clinical trials and commercial production. Evaluate the manufacturer's capacity to scale as demand increases.

Cost and Lead Time:
Asian manufacturers generally offer competitive pricing and shorter lead times, whereas European and North American suppliers may charge premium but provide stronger regulatory confidence.

Intellectual Property & Confidentiality:
Given CIDA-STAT’s potential patent considerations, engage with suppliers under confidentiality agreements and clarify IP protections.

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Recent Trends and Developments

The global API market continues to evolve with increased focus on quality, supply chain resilience, and regulatory compliance. For complex molecules like CIDA-STAT, manufacturers are adopting continuous manufacturing processes and advanced analytical technologies to ensure consistency.

Emerging suppliers from India and China are gaining accreditation and expanding capacity, making them increasingly viable options. Moreover, some pharmaceutical companies are developing in-house synthesis capabilities or partnering with Contract Manufacturing Organizations (CMOs) to secure supply chains.

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Challenges in API Sourcing for CIDA-STAT

• Complex Synthesis Routes:
  CIDA-STAT’s synthesis involves multi-step reactions with stereochemical considerations, which restricts the pool of capable manufacturers.

• Regulatory Hurdles:
  Ensuring the API meets international standards is critical, especially for clinical trial material, which often necessitates strict compliance with FDA/EMA regulations.

• Intellectual Property Concerns:
  Proprietary synthesis processes require confidential handling and contractual safeguards.

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Conclusion

The sourcing landscape for CIDA-STAT API is diverse, with reputable manufacturers across North America, Europe, and Asia. While established multinationals like BASF, Evonik, and Hovione offer proven quality and compliance, emerging Asian manufacturers provide cost-effective alternatives with rapidly expanding capacity.

Business professionals should prioritize API suppliers with proven GMP compliance, robust QC systems, and reliable supply chains. Strategic partnerships with these manufacturers facilitate seamless transition from development to commercial production while maintaining regulatory integrity.

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Key Takeaways

• High-Quality API sourcing is critical for CIDA-STAT’s development and commercial success.
• Global manufacturers from North America, Europe, and Asia offer diverse options; selection depends on quality standards, cost, and regulatory considerations.
• Prioritize suppliers with GMP accreditation, comprehensive QC, and supply chain stability.
• Consider emerging markets for cost advantage, but verify regulatory compliance and manufacturing capabilities rigorously.
• Early engagement and clear contractual agreements mitigate risks related to IP, quality, and supply continuity.

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FAQs

Q1: What are the primary criteria for selecting an API manufacturer for CIDA-STAT?
A1: The key criteria include GMP compliance, high API purity (>98%), robust QC protocols, supply capacity, regulatory track record, and confidentiality arrangements safeguarding IP.

Q2: Are there any regional preferences for sourcing CIDA-STAT APIs?
A2: Preferences depend on regulatory pathways, cost considerations, and supply reliability. North America and Europe are favored for regulatory confidence, while Asia offers cost advantages and flexible capacity.

Q3: Can smaller or boutique manufacturers reliably produce CIDA-STAT API?
A3: Yes, provided they have validated synthesis processes and GMP certifications. Smaller firms often offer flexibility and rapid turnaround, especially in early-stage development.

Q4: How does supply chain security impact API sourcing for CIDA-STAT?
A4: Reliable supply chains prevent delays, minimize batch failures, and support regulatory compliance. Long-term agreements with multiple suppliers or geographic diversification are strategic approaches.

Q5: What regulatory documentation should suppliers provide?
A5: Suppliers should provide Certificates of Analysis, GMP compliance certificates, stability data, process validation documents, and batch records to ensure API quality and regulatory readiness.

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References

1. [1] U.S. Food and Drug Administration (FDA). Good Manufacturing Practice (GMP) Regulations.
2. [2] European Medicines Agency (EMA). Good Manufacturing Practices (GMP) guidelines.
3. [3] GlobalData. API Market Trends and Outlook 2023.
4. [4] Contract Pharmacal Manufacturing: Manufacturing Capabilities & Compliance Standards.
5. [5] Industry Reports on Asian API Manufacturers’ GMP Certifications and Capacity.