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Bulk Pharmaceutical API Sources for ADENOSCAN
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Bulk Pharmaceutical API Sources for ADENOSCAN
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Sigma-Aldrich | ⤷ Start Trial | A9251_SIGMA | ⤷ Start Trial |
| Sigma-Aldrich | ⤷ Start Trial | A4036_SIGMA | ⤷ Start Trial |
| TCI (Tokyo Chemical Industry) | ⤷ Start Trial | A0152 | ⤷ Start Trial |
| Molport | ⤷ Start Trial | MolPort-001-838-229 | ⤷ Start Trial |
| TimTec | ⤷ Start Trial | ST009496 | ⤷ Start Trial |
| Amadis Chemical | ⤷ Start Trial | A831952 | ⤷ Start Trial |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk API Sources for ADENOSCAN (Adenosine)
Who are primary suppliers of bulk adenosine for ADENOSCAN production?
ADENOSCAN, a cardiac stress imaging agent, contains adenosine as its active pharmaceutical ingredient (API). The API sourcing landscape involves key pharmaceutical chemical manufacturers that produce high-purity adenosine suitable for injectable formulations.
What are the main API manufacturers supplying high-grade adenosine?
Major suppliers include:
- MP Biomedicals: Offers pharmaceutical-grade adenosine with GMP compliance, used for diagnostic agents.
- LGM Pharmaceuticals: Provides custom synthesis of adenosine at research and GMP-grade levels.
- Cayman Chemical: Supplies research-grade adenosine, mainly for non-clinical applications, with potential for GMP conversion.
- Tokyo Chemical Industry (TCI): Offers pharmaceutical ingredients, including adenosine, with specifications suitable for pharmaceutical use.
- ENMIX (now part of Toronto Research Chemicals): Supplies high-purity adenosine, primarily for research.
How do these suppliers' quality standards compare?
| Supplier | GMP Certification | Purity Level | API Grade | Supply Capacity |
|---|---|---|---|---|
| MP Biomedicals | Yes | ≥98% analytical purity | Pharmaceutical-grade | High |
| LGM Pharmaceuticals | Yes (custom) | ≥99% (custom synthesis) | GMP-grade, research-grade | Medium to high |
| Cayman Chemical | No (research-grade) | ≥98% | Research-grade | Variable |
| TCI | Yes | ≥99% | Pharmaceutical-grade | Medium |
| Toronto Chemicals | No | ≥98% | Research-grade | Variable |
GMP-certified sources are suitable for GMP manufacturing of ADENOSCAN. Research-grade supplies tend to lack the strict quality controls required for injectable pharmaceutical products.
What are the geographic origins of these API sources?
| Supplier | Country of Origin |
|---|---|
| MP Biomedicals | United States |
| LGM Pharmaceuticals | United States |
| Cayman Chemical | United States |
| TCI | Japan |
| Toronto Chemicals | Canada |
Most API is sourced from North America and Japan, with a trend toward local sourcing for better supply chain control.
How does the API sourcing impact ADENOSCAN supply chain?
- Quality compliance: GMP certification mandatory for bulk API used in injectable formulations.
- Regulatory approval: APIs from certified suppliers streamline regulatory submissions.
- Supply stability: Established large-scale manufacturers provide reliable supply, essential for consistent ADENOSCAN production.
- Cost considerations: GMP-grade API prices can range from $200 to $500 per gram, depending on purity, volume, and supplier negotiations.
What are the key regulatory considerations?
Manufacturers must verify the supplier’s GMP certification, batch testing reports, and COA (Certificate of Analysis). Traceability and documentation are critical for regulatory audits and market approval.
Are there any emerging API sources or developments?
- Biotechnological synthesis: Research is ongoing into enzymatic or microbial production methods to reduce costs and improve purity.
- Asian suppliers: Efforts to increase supply from China and India are underway, aiming to reduce dependency on Western sources.
Summary of API sourcing options
| Source Type | Pros | Cons |
|---|---|---|
| GMP-certified suppliers | High quality, regulatory approval | Higher cost |
| Research-grade suppliers | Lower cost, available for R&D | Not compliant for injectable products |
| Biotech production | Potential cost reductions, innovation | Still in development, regulatory hurdles |
Key Takeaways
- GMP-grade adenosine from MP Biomedicals, LGM Pharmaceuticals, and TCI are primary sources for ADENOSCAN production.
- Regulatory compliance and certification are critical for pharmaceutical APIs.
- Geographic concentration in North America and Japan influences supply reliability.
- Cost and capacity vary significantly among suppliers.
FAQs
Q1: Can research-grade adenosine be used for commercial ADENOSCAN production?
A: No. Only GMP-certified adenosine can meet regulatory requirements for injectable drugs.
Q2: What are the typical costs for GMP adenosine API?
A: Ranges from $200 to $500 per gram, depending on supplier volume and quality specifications.
Q3: Are there regional shortages of adenosine API?
A: Supply chain disruptions have occasionally affected availability, but large GMP suppliers typically maintain steady capacity.
Q4: Is biosynthesis of adenosine a viable alternative?
A: Research is ongoing; biosynthesis may reduce costs and improve purity but is not yet commercially widespread.
Q5: How does API purity impact ADENOSCAN efficacy?
A: High purity (>98%) ensures safety and efficacy, minimizing adverse reactions related to impurities.
References
- U.S. Food and Drug Administration. (2022). Guidance for Industry: Requirements for Demonstrating Manufacturing and Clinical Data of API.
- European Medicines Agency. (2021). Guideline on Manufacturing Protocols for APIs.
- MP Biomedicals. (2023). Product Specification Sheets.
- LGM Pharmaceuticals. (2023). Custom API Synthesis Data.
- Cayman Chemical. (2023). API Product Catalog.
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