Suppliers and packagers for ASCLERA

ASCLERA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chemisch Fbrk Krsslr	ASCLERA	polidocanol	SOLUTION;INTRAVENOUS	021201	NDA	Methapharm, Inc	67850-140-05	2 mL in 1 AMPULE (67850-140-05)	2010-06-01
Chemisch Fbrk Krsslr	ASCLERA	polidocanol	SOLUTION;INTRAVENOUS	021201	NDA	Methapharm, Inc	67850-141-05	2 mL in 1 AMPULE (67850-141-05)	2010-06-01

Suppliers for the Pharmaceutical Drug Asclera: A Comprehensive Overview

Last updated: July 31, 2025

Introduction

Asclera, a branded formulation of Streptococcus pyogenes-derived botulinum toxin, primarily marketed for the treatment of vascular anomalies such as varicose veins and spider veins, has gained recognition within the dermatological and vascular treatment markets. Asclera’s active component is Clostridium botulinum toxin type A, a biologic agent that necessitates a highly specialized and regulated supply chain involving cultivation, purification, formulation, and distribution. This analysis provides an in-depth overview of the key suppliers involved in the manufacturing and distribution of Asclera, examining each stage of the supply chain, including raw material providers, manufacturing partners, and distribution channels.

Manufacturing and Active Pharmaceutical Ingredient (API) Supply Chain

1. Primary Active Ingredient Supplier

Medytox Inc. holds the licensing and manufacturing rights for Asclera, originally developed by Medicis Pharmaceutical (a division of Valeant Pharmaceuticals, now part of Bausch Health Companies). The production of botulinum toxin type A involves fermentation of Clostridium botulinum strains, followed by complex purification processes to obtain the active component.

• Medytox Inc. is a South Korean biopharmaceutical company that specializes in botulinum toxin formulations. They are the primary supplier of the API used in Asclera, ensuring supply chain security for the product.

• Other Potential API Suppliers: While Medytox is the main manufacturer, several companies globally produce botulinum toxins, including Merz Pharma, Ipsen, and Revance Therapeutics, but these are associated with different commercial products. For Asclera, Medytox remains the primary source.

2. Raw Material Suppliers

The production of botulinum toxins requires specific raw materials, notably:

• Clostridium botulinum strains.
• Specialized fermentation media.
• Purification reagents and chromatography resins.

Key Raw Material Suppliers:

• Sigma-Aldrich (Merck KGaA): Supplies fermentation media components, chromatography resins, and purification chemicals. They play a critical role in providing high-quality reagents necessary for the toxin manufacturing process.

• Thermo Fisher Scientific: Supplies reagents, enzymes, and supplies used in downstream processing, including purification and formulation.

These raw materials must meet stringent pharmacopeial standards, given the biological nature of the product and the criticality of purity and safety.

Manufacturing Partners

Medytox, effectively, functions as the core manufacturing entity for Asclera, overseeing the fermentation, purification, and formulation processes. The manufacturing process involves:

• Fermentation of Clostridium botulinum.
• Purification via chromatography methods.
• Lyophilization for product stability.
• Filling, finishing, and packaging.

Partnerships with Contract Manufacturing Organizations (CMOs) are common in biopharmaceutical production, especially for scaling or quality assurance. While specific CMO partnerships for Asclera are proprietary, industry trends suggest reliance on specialized CDMOs with verified biosafety and Good Manufacturing Practice (GMP) compliance.

Distribution and Supply Chain

1. Distribution Channels

Once manufactured, Asclera is distributed globally through a network of specialty distributors, hospital pharmacies, and authorized distributors.

• Bausch Health Companies, the current marketer of Asclera, manages global distribution logistics, ensuring product integrity from manufacturing facilities to regional markets.

• Distribution Partners: Different regions may have local distributors specializing in biologics and injectables, including major players such as McKesson, Cardinal Health, and AmerisourceBergen.

2. Cold Chain and Storage

Asclera, being a biologic, requires strict cold chain logistics—maintaining temperatures typically between 2°C to 8°C—to preserve potency and safety throughout transit and storage.

• Transport Providers: Specialized logistics firms such as World Courier and FedEx Medical Express manage temperature-sensitive shipping.

• Storage Facilities: Hospitals and clinics storing Asclera adhere to strict temperature controls, with inventory management systems ensuring product quality and expiration tracking.

Regulatory and Quality Considerations

Suppliers and distributors must adhere to regulatory standards from authorities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

• GMP Compliance: All manufacturing and raw material suppliers are required to operate under GMP standards to ensure safety, potency, and purity.

• Batch Testing and Certification: Each batch of Asclera undergoes rigorous testing for potency, sterility, and safety. The suppliers involved are responsible for providing the necessary Certificates of Analysis (CoA).

Emerging Trends and Supply Chain Challenges

The biologic nature of Asclera introduces vulnerabilities such as supply disruptions due to contamination, manufacturing setbacks, or raw material shortages. Recent industry shifts emphasize:

• Supply Chain Diversification: To mitigate risks, Bausch and Medytox may seek alternative raw material or API suppliers, including geographic diversification to include manufacturers in Europe, Asia, or North America.

• Regulatory Harmonization: To streamline approval and manufacturing processes, suppliers are increasingly adhering to international standards such as ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients).

• Biologics Market Dynamics: Growing demand for botulinum toxin products reflects increased competition, emphasizing the importance of reliable suppliers for sustained market share.

Key Considerations for Business Professionals

• Ensuring supply chain resilience requires active engagement with primary API manufacturers like Medytox and raw material suppliers such as Merck and Thermo Fisher.
• Strategic partnerships with logistics providers specializing in cold chain management are vital to maintaining product integrity.
• Monitoring regulatory compliance across tiers of the supply chain minimizes the risk of delays or product recalls.
• Diversification of raw material sources can safeguard against regional disruptions.
• Transparency and traceability, facilitated by digital supply chain management systems, enhance quality control and regulatory compliance.

Key Takeaways

• Medytox is the primary manufacturer of the API and bulk production of Asclera, with a complex supply chain involving high-quality raw materials from specialized suppliers.
• Raw materials such as fermentation media and chromatography resins are sourced primarily from global leaders like Sigma-Aldrich and Thermo Fisher.
• Distribution relies on a global network of experienced logistics providers, with strict cold chain requirements to preserve biologic integrity.
• Regulatory compliance and quality assurance at each supply chain level are crucial for product safety and market approval.
• Supply chain resilience and diversification remain critical, especially amid industry growth and potential geopolitical or logistical disruptions.

FAQs

1. Who are the main manufacturers of Asclera’s active ingredient?
Medytox Inc. is the primary manufacturer of the botulinum toxin used in Asclera, producing the active pharmaceutical ingredient through fermentation and purification processes.

2. What raw materials are involved in producing Asclera?
Key raw materials include Clostridium botulinum strains, fermentation media, chromatography resins, and purification reagents supplied by companies like Sigma-Aldrich and Thermo Fisher Scientific.

3. How is Asclera distributed globally?
It is distributed via a network of specialty distributors, hospital pharmacies, and logistics providers, with strict cold chain protocols managed by companies such as FedEx and World Courier.

4. Are there alternative suppliers for Asclera’s API or raw materials?
Currently, Medytox is the primary API supplier, but industry trends suggest exploring alternative sources to mitigate supply chain risks.

5. What regulatory standards govern the supply chain of Asclera?
Suppliers and manufacturers must comply with GMP standards set by regulatory authorities like FDA and EMA to ensure product quality and safety.

References

[1] European Medicines Agency (EMA). "Botulinum Toxin." EMA, 2022.
[2] Medytox Inc. Corporate Overview. Medytox, 2023.
[3] Sigma-Aldrich. "Fermentation Media and Chromatography Resins." Merck KGaA, 2023.
[4] FedEx. "Cold Chain Logistics for Biologics." FedEx, 2023.
[5] U.S. Food and Drug Administration (FDA). "Biologics Manufacturing Practices." FDA, 2022.