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Bulk Pharmaceutical API Sources for ORAVERSE
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Bulk Pharmaceutical API Sources for ORAVERSE
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Sigma-Aldrich | ⤷ Start Trial | P7561_SIGMA | ⤷ Start Trial |
| Molport | ⤷ Start Trial | MolPort-003-959-154 | ⤷ Start Trial |
| Hangzhou APIChem Technology | ⤷ Start Trial | AC-7472 | ⤷ Start Trial |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk API Sources for Oraverse
Oraverse is a proprietary formulation of phentolamine mesylate, used to reverse local anesthetic effects and reduce soft tissue anesthesia after dental procedures. The active pharmaceutical ingredient (API) in Oraverse is phentolamine mesylate.
Where is Phentolamine Mesylate Manufactured?
Phentolamine mesylate is a synthetic non-selective alpha-adrenergic antagonist produced primarily by specialized chemical and pharmaceutical contract manufacturers.
Key API Suppliers and Manufacturers
| Supplier / Manufacturer | Location | Capabilities | Notes |
|---|---|---|---|
| Sino Biopharmaceutical Ltd. | China | Produces bulk phentolamine mesylate for pharmaceutical use | Major Chinese supplier with GMP certification |
| Boschemi, S.p.A. | Italy | Produces high-purity APIs, including phentolamine mesylate | Known for high-quality pharmaceutical intermediates |
| Hospira (Pfizer subsidiary) | United States | Contract manufacturing of APIs, including phentolamine | Focus on sterile and injectable APIs |
| CordenPharma | Switzerland | Custom manufacturing, including alpha-adrenergic antagonists | Offers complex API synthesis capabilities |
Contract Manufacturing and Sourcing
Most commercial supply of phentolamine mesylate comes from contract manufacturing organizations (CMOs). These firms operate under strict Good Manufacturing Practice (GMP) standards, ensuring API purity and compliance with regulatory bodies.
API Quality and Regulatory Standards
- GMP certification is essential for APIs intended for human use.
- Purity levels typically exceed 99%, with residual solvents and heavy metals below permissible limits.
- Certificates of Analysis (CoA) are provided to confirm batch consistency and compliance.
Supply Chain Considerations
- Lead times range from 4 to 12 weeks, depending on source and volume.
- Major suppliers maintain stock for emergency and large-scale production.
- Geographical diversification reduces supply risk.
Market Dynamics
The market for bulk phentolamine mesylate is limited, with few producers capable of handling its synthesis due to its complex chemical structure. The primary consumers are pharmaceutical companies developing or producing formulations like Oraverse.
Regulatory Landscape
API sources must adhere to:
- U.S. Food and Drug Administration (FDA) standards.
- European Medicines Agency (EMA) regulations.
- International standards such as ICH Q7 for APIs.
Summary of Major Sources
| Supplier Name | Certification | Capacity | Remarks |
|---|---|---|---|
| Sino Biopharmaceutical Ltd. | GMP | High | Large-scale Chinese producer |
| CordenPharma | GMP | Medium | Specialized API synthesis |
| Boschemi S.p.A. | GMP | Medium | High purity APIs |
| Contract manufacturers linked via pharma supply chains | GMP | Variable | Key for large-volume production |
Strategic Considerations
- Most API sources have a regional focus, with Asian and European suppliers dominating.
- Existing supply chains are resilient but require monitoring for geopolitical or regulatory disruptions.
- Quality assurance remains critical due to the sensitive nature of alpha-adrenergic antagonists.
Key Takeaways
- Phentolamine mesylate API is produced mainly by Chinese and European manufacturers under GMP.
- Contract manufacturing organizations handle most supply, with lead times influenced by order size.
- Regulatory compliance and purity standards are strict, especially for injectable APIs like phentolamine.
- Supply chain diversification reduces risk, but capacity constraints exist among few high-quality suppliers.
FAQs
Q1: Can I source bulk phentolamine mesylate directly for formulation development?
Yes, multiple GMP-certified manufacturers provide bulk phentolamine mesylate suitable for pharmaceutical formulation and clinical research.
Q2: Are there regional restrictions on API importation for phentolamine mesylate?
Regulations vary; imports into the U.S. and EU require compliance with local GMP and import standards.
Q3: What is the typical lead time for bulk API orders?
Lead times are generally between 4-12 weeks, depending on the supplier and volume.
Q4: What quality standards should API suppliers meet for dental applications like Oraverse?
Suppliers must comply with GMP standards, providing certificates of analysis confirming high purity, low residual solvents, and heavy metal content.
Q5: Are there any alternate sources of phentolamine mesylate?
Alternate sources are limited; the main supplies are from established contract manufacturers in China, Europe, and the U.S.
References
[1] U.S. Food and Drug Administration. (2020). Good Manufacturing Practices for Active Pharmaceutical Ingredients. FDA.
[2] European Medicines Agency. (2021). Quality Requirements for APIs. EMA.
[3] ICH Expert Working Group. (2013). ICH Q7(R2): Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. International Council for Harmonisation.
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