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Suppliers and packagers for lumisight
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lumisight
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lumicell | LUMISIGHT | pegulicianine acetate | POWDER;INTRAVENOUS | 214511 | NDA | Lumicell, Inc. | 82292-040-10 | 10 VIAL in 1 CARTON (82292-040-10) / 3.9 mL in 1 VIAL (82292-040-01) | 2024-04-17 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LUMISIGHT
Introduction
LUMISIGHT (also known as phentolamine mesylate), marketed under various brand names, is a pharmacological agent primarily utilized in procedures such as eyebrow and eyelid tattooing, as well as other cosmetic and medical applications requiring temporary vasodilation. As a specialized drug, sourcing reliable manufacturing and supply chain channels is critical for healthcare providers, pharmacies, and distributors aiming to maintain consistency, regulatory compliance, and cost-effectiveness. This article explores the landscape of suppliers for LUMISIGHT, features key manufacturers, and discusses procurement considerations in this niche pharmaceutical market.
Overview of LUMISIGHT and Its Market
LUMISIGHT is a trade name for phentolamine mesylate, an alpha-adrenergic antagonist that induces vasodilation by blocking alpha-adrenergic receptors. It is used in reversal agents for vasoconstrictors such as epinephrine, and in cosmetic procedures, it facilitates the correction of over-tinted or overly pigmented areas by increasing blood flow.
The market for phentolamine mesylate, including LUMISIGHT, is characterized by limited producers, primarily because it is a specialized pharmaceutical ingredient with specific sterilization and regulatory requirements.
Key Manufacturers and Suppliers of LUMISIGHT / Phentolamine Mesylate
1. Chinese and Indian API Manufacturers
The bulk of phentolamine mesylate APIs (Active Pharmaceutical Ingredients) originate from China and India, which are prominent hubs for generic and specialized pharmaceutical manufacturing.
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SinoPharm and Shanghai First Pharmaceutical (China): These companies are known for producing high-quality APIs, including phentolamine mesylate, for export to global pharmaceutical markets. They typically supply active ingredients to pharmaceutical firms that formulate finished products.
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Bangalore-based API Suppliers: Several Indian API manufacturers such as Sun Pharma and Divi's Laboratories produce phentolamine mesylate for export. Although primarily focused on generic markets, some of these companies may supply OEMs (Original Equipment Manufacturers) or raw material distributors.
2. Contract Manufacturing Organizations (CMOs)
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Patheon (part of Thermo Fisher Scientific): Offers contract manufacturing for APIs and finished pharmaceuticals, including specialized compounds like phentolamine mesylate, tailored to client specifications, with strict compliance to global GMP standards.
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Recipharm: Provides API manufacturing and formulation services, often sourcing APIs including vasodilators like phentolamine for global pharmaceutical clients.
3. Patent Holders and Brand Suppliers
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AbbVie (Historically associated with formulations): Although their primary focus has been on more prominent therapeutics, AbbVie’s presence as a supplier for formulations containing phentolamine is limited but notable.
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Laboratories Managing Licensed Production: Sometimes, proprietary formulations (such as LUMISIGHT) are manufactured by tiered licensing arrangements with pharmaceutical companies assigned to market or distribute specific branded products in different regions.
Distribution Channels and Global Supply Chains
Due to the specialty nature of LUMISIGHT, distributors typically procure the API directly from manufacturers or via authorized regional distributors. In many cases, regional pharmaceutical distributors or wholesalers in North America, Europe, and Asia facilitate timely procurement.
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Asia-based Distributors: Prominent for sourcing raw material APIs, offering competitive pricing, but companies must verify GMP compliance and authenticity.
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European and North American Suppliers: These are often smaller, quality-controlled entities specializing in regulated pharmaceutical ingredients, including phentolamine mesylate.
Regulatory Considerations for Suppliers
Regulatory compliance remains a critical factor. Suppliers must adhere to Good Manufacturing Practices (GMP)s mandated by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and corresponding national authorities.
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The FDA requires rigorous documentation and validation for API suppliers exporting to the U.S., including batch records, stability data, and validation certificates.
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EMA and MHRA (UK) standards similarly govern European suppliers, emphasizing transparency in manufacturing procedures and batch consistency.
Many API suppliers hold ISO 9001 and GMP certifications, guaranteeing product quality and traceability.
Procurement Challenges and Strategies
Limited Number of Suppliers: The production of phentolamine mesylate is somewhat niche, resulting in a limited number of qualified suppliers.
Regulatory Variability: Different regions have divergent approval statuses, impacting supplier accessibility—for instance, some APIs may be approved in Asia but not yet in other markets.
Counterfeit and Quality Assurance Risks: Due diligence in supplier vetting is crucial; relying on unverified sources increases compliance risks and potential legal liability.
Supply Chain Disruptions: Global logistics issues, especially during pandemic conditions, can affect availability. Establishing multiple supplier relationships and maintaining buffer inventories mitigate this risk.
Strategic Recommendations
- Collaborate exclusively with manufacturers holding proven GMP certifications.
- Conduct thorough supplier audits and review regulatory documentation.
- Engage regional distributors with established reputations and comprehensive quality assurance programs.
- Monitor regulatory updates for phentolamine mesylate approvals in target markets.
Conclusion
The supply landscape for LUMISIGHT, largely comprising phentolamine mesylate, is concentrated among select API manufacturers in China, India, and specialized Western contract manufacturers. Due diligence and validation of regulatory compliance underpin successful procurement. As demand for cosmetic and medical vasodilation agents grows, so too will the importance of establishing robust, compliant supply chains with trusted manufacturers.
Key Takeaways
- The primary suppliers of LUMISIGHT are Chinese and Indian API manufacturers, with select Western CMOs providing contract manufacturing services.
- Ensuring GMP compliance and regulatory approval is essential in selecting suppliers to mitigate risks.
- Supply chain stability depends on diversifying sources, conducting thorough vetting, and maintaining regulatory awareness.
- Market growth in cosmetic and medical applications may lead to increased manufacturing capacity and supplier diversity.
- Strategic procurement and compliance are vital for securing reliable and high-quality LUMISIGHT supplies.
Frequently Asked Questions (FAQs)
1. Who are the main global suppliers of phentolamine mesylate for pharmaceutical use?
Most suppliers originate from China and India, with some contract manufacturers in Europe and North America providing formulation services. Specific companies include SinoPharm, Sun Pharma, and Recipharm, among others.
2. What regulatory standards should suppliers meet when providing LUMISIGHT?
Suppliers must adhere to GMP standards, possess relevant certifications (ISO 9001, GMP), and comply with regional regulatory agencies such as the FDA and EMA.
3. Can LUMISIGHT be sourced directly from brand manufacturers, or only through APIs?
Typically, healthcare providers and formulators source the API (phentolamine mesylate) directly from API manufacturers. Branded formulations like LUMISIGHT are produced under licensing agreements and may be available through authorized distributors.
4. What are the risks associated with sourcing LUMISIGHT from unverified suppliers?
Risks include receiving substandard or counterfeit products, non-compliance with regulatory requirements, and potential legal liabilities if products do not meet safety standards.
5. How might market trends influence the future supply landscape for LUMISIGHT?
Growing demand in cosmetic procedures and reversal agents may incentivize manufacturers to expand capacity and improve supply chain robustness, potentially increasing supplier options and competitive pricing.
References
[1] U.S. Food and Drug Administration. (2022). Guidance for Industry: Active Pharmaceutical Ingredient (API) Manufacturing.
[2] European Medicines Agency. (2022). Quality standards for active substances.
[3] MarketsandMarkets. (2021). Phentolamine Market Analysis & Opportunity.
[4] IMS Health. (2022). Global API Manufacturing & Supply Chain Report.
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