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Alfigio Accelerates Magnesium CDMO Capabilities

Magnesium composite soft capsule products jointly developed by Alfibio. Dong -A Pharmaceutical Mag and Bifidolx (left) and Yuhan Magbi X. [사진=알피바이오]

Alfibio Targets Magnesium Expansion, Redefining it as a ‘Multi-Functional Platform Raw Material’

SEOUL, South Korea – Alfibio, a leading contract progress and manufacturing association (CDMO) for pharmaceuticals and health functional foods, announced a strategic expansion of its portfolio, focusing on magnesium as a versatile, multi-functional ingredient. The company aims to solidify its position as a high value-added CDMO by rebranding magnesium beyond its mineral classification, envisioning it as a thorough “multi-functional platform raw material” for the global market.

This strategic pivot underscores Alfibio’s commitment to diversifying its B2B customized solutions. The company projects a notable growth in magnesium-based product development, targeting an expansion of over 300% by 2030. this ambitious goal reflects the growing recognition of magnesium’s broad-spectrum health benefits.

Magnesium plays a crucial role in supporting numerous physiological functions. It is widely acknowledged for its benefits to athletes, aiding in muscle recovery and cramp prevention. Beyond athletic performance,magnesium is effective in alleviating pre-menstrual syndrome (PMS) symptoms and enhancing bone health. Furthermore, emerging research highlights its positive impact on sleep quality, anxiety reduction, and overall cardiovascular and neurological well-being.

The global market for magnesium supplements is poised for ample growth. According to global market research firm Grand View Research, the market is expected to expand from an estimated $29.3 million in 2024 to $40.8 million by 2030, demonstrating a compound annual growth rate (CAGR) of 5.7% between 2025 and 2030.

Alfibio has already demonstrated its innovative capabilities through recent collaborations. The company successfully manufactured Dong-A Pharm’s ‘Maglang Bifidolx’ soft capsules, enhancing their product line following its work with Yuhan corporation’s ‘Magbi X’. In these collaborations, Alfibio applied its advanced drug delivery system (DDS) technology, utilizing Dong-A Pharmaceuticals’ patented ‘Pidolate and Vitamin B1 Combination Composition’.This innovative approach considerably boosts absorption efficiency compared to conventional magnesium formulations, ensuring both stability and enhanced uptake of the key ingredient.

“Magnesium is a truly remarkable multi-platform raw material,” stated Yoon Soo-jeong, Managing Director at Alfibio.”Its potential extends far beyond its basic mineral properties, offering vast opportunities for innovative functional combinations and product development.”

How does Alfigio address the bioavailability challenges commonly associated with magnesium salts?

Alfigio Accelerates Magnesium CDMO Capabilities

Expanding Horizons in Magnesium-Based Pharmaceutical Advancement

Alfigio,a leading Contract Development adn Manufacturing Organization (CDMO),is significantly bolstering its capabilities in the development and manufacturing of magnesium-based pharmaceutical ingredients. This strategic expansion addresses the growing demand for magnesium compounds in various therapeutic areas, including cardiovascular health, neurological disorders, and nutritional supplements. The move positions Alfigio as a key partner for pharmaceutical companies seeking specialized expertise in magnesium CDMO services.

The Rising Importance of Magnesium in Pharmaceuticals

Magnesium is an essential mineral involved in over 300 enzymatic reactions within the human body. Its therapeutic applications are diverse, driving increased research and development of magnesium-containing drugs. Several factors contribute to this growth:

Bioavailability Challenges: Many common magnesium salts exhibit poor bioavailability. Alfigio’s focus includes developing innovative formulations to enhance absorption and efficacy.

New Therapeutic Applications: Ongoing research is uncovering new potential uses for magnesium in areas like migraine prevention, anxiety reduction, and even cancer treatment.

Personalized Nutrition: The growing trend towards personalized nutrition is fueling demand for high-quality magnesium supplements tailored to individual needs.

Demand for Complex Magnesium salts: beyond magnesium oxide and citrate, there’s increasing interest in more complex salts like magnesium glycinate, threonate, and taurate, requiring specialized manufacturing expertise.

Alfigio’s Enhanced magnesium CDMO Offerings

Alfigio’s investment encompasses several key areas to provide a comprehensive suite of magnesium pharmaceutical manufacturing services:

Expanded Manufacturing Capacity: New, dedicated production suites have been established, equipped with state-of-the-art reactors and processing equipment optimized for magnesium chemistry.

Advanced Analytical Capabilities: Investment in cutting-edge analytical instrumentation, including ICP-MS (Inductively Coupled Plasma Mass Spectrometry) and XRD (X-ray Diffraction), ensures rigorous quality control and characterization of magnesium compounds. This is crucial for meeting stringent regulatory requirements.

Formulation Development Expertise: Alfigio’s formulation scientists specialize in developing stable, bioavailable, and patient-pleasant dosage forms containing magnesium. This includes:

Tablets and Capsules

powders and Granulates

Liquid Formulations

Effervescent Tablets

Process Development & Optimization: Alfigio offers robust process development services to optimize magnesium salt synthesis, purification, and crystallization, leading to cost-effective and scalable manufacturing processes.

Regulatory Support: A dedicated regulatory affairs team provides comprehensive support for IND (Investigational New Drug) and NDA (New Drug Application) filings, ensuring compliance with global regulations (FDA, EMA, etc.).

Specific Magnesium Compounds Supported

Alfigio’s expanded capabilities cover a wide range of magnesium compounds, including but not limited to:

Magnesium Oxide

Magnesium Citrate

Magnesium Chloride

Magnesium Sulfate (Epsom Salts)

Magnesium Glycinate

Magnesium Threonate

Magnesium Taurate

Magnesium Aspartate

This broad range allows Alfigio to cater to diverse client needs across various pharmaceutical and nutraceutical applications. The company also offers custom synthesis of specialized magnesium salts based on client specifications.

Benefits of Partnering with Alfigio for Magnesium CDMO

Choosing Alfigio as your magnesium API manufacturer offers several key advantages:

Reduced Time to Market: Streamlined processes and dedicated resources accelerate development timelines.

Cost-Effectiveness: Optimized manufacturing processes and economies of scale translate into competitive pricing.

High Quality & Reliability: Stringent quality control measures and adherence to cGMP (current Good Manufacturing Practice) standards ensure product integrity.

Scalability: Flexible manufacturing capacity allows for seamless scale-up from clinical trial materials to commercial production.

Expertise & Innovation: A team of experienced scientists and engineers provides specialized knowledge and innovative solutions.

Quality Assurance and Regulatory Compliance

Alfigio operates under a robust Quality Management System (QMS) compliant with global regulatory standards. Key aspects include:

cGMP Compliance: All manufacturing processes adhere to cGMP guidelines.

Comprehensive Documentation: Detailed batch records, analytical reports, and validation studies are maintained.

Regular Audits: Alfigio undergoes regular audits by regulatory agencies and clients to ensure ongoing compliance.

Stability Studies: Comprehensive stability studies are conducted to determine product shelf life and storage conditions.

Traceability: Full traceability of raw materials and finished products is maintained throughout the manufacturing process.

Real-World Application: Enhancing Magnesium Glycinate Bioavailability

A recent project involved collaborating with a nutraceutical company to improve the bioavailability of magnesium glycinate. Alfigio’s formulation team developed a novel microencapsulation technique that significantly enhanced absorption in in vitro* studies. This resulted in a more effective supplement with a lower required dosage, ultimately benefiting the end consumer. This demonstrates Alfigio’s commitment to magnesium formulation development.

Future Outlook: Continued Investment in Magnesium Technology

Alfigio is committed to ongoing investment in magnesium technology and capabilities. Future plans include exploring continuous manufacturing processes and developing novel magnesium-based drug delivery systems. This dedication ensures Alfigio remains at the forefront of magnesium CDMO innovation, providing clients with cutting-edge solutions for their pharmaceutical

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