Bushu Pharmaceuticals Ltd.

None Drug Loss: A growing concern in Japan, but there is something new on the horizon.The Japanese life science industry is currently facing a social problem known as "drug loss."  Approximately 70% of NCEs commercialized in the U.S. and Europe have not yet been introduced in Japan during the last five years.  This discrepancy rate has been increasing and many rare disease drugs never reach Japanese patients due to regulatory and commercially unique barriers.  In response to this pressing concern, the Japanese authorities have initiated regulatory reforms to be more efficient in the drug development and marketing approval process, such as not requiring a Phase 1 study.  These MHLW regulation changes are welcoming for the private sector, and it motivates companies to re-evaluate the Japanese market, since the Japanese market is large due to the aging population and a good reimbursement package for every citizen.  However, it may not be enough for companies to re-evaluate Japanese market entry.  The next question is how best do we enter the Japanese market with a profitable business structure? The solution is the J-ENTRY Consortium (JEC), especially for mid-sized or small-size assets.  Let's see how JEC provides you with a Japanese business opportunity.  The J-ENTRY Consortium, the right platform for the right entryAs business professionals, we are expected to have our product assets projected to cover all essential expenses before entering a new market.  Typically, a market like Japan needs to exceed the minimum size for licensing or setting up a subsidiary.  But, what would you think if you had another option to minimize this barrier? This is where the JEC provides a different landscape to change this kind of pre-determined criteria.  Highlight 1: One-stop solutionFinding the right partner(s) in Japan that have multiple capabilities can be challenging. JEC provides a one-stop and end-to-end solution, including regulatory and operational capabilities with proven experience.  One of the key companies in the Consortium is SKK. With over 70 years of history in Japan as a pharmaceutical company, they will manage all tasks from end to end; from the clinical trials, regulatory J-NDA filing, manufacturing and Japanese commercialization as a delegate of your company.  Or you also might have faced cultural differences in the packaging since the Japanese market typically requires unique final packages.  Another key company in our consortium is Bushu Pharma. With 26 years in the CDMO business, Bushu Pharma has regularly passed foreign audits, including the FDA and EMA. Furthermore, Suzuken, a leading Japanese pharmaceutical distributor with 80+ years of history, will seamlessly support delivery of your products to patients.  No need to worry about the commercial communication difficulties, just connect with SKK.  Highlight 2: No initial investment and physical presenceYou may need to prepare a clinical package even with a drug-loss asset.  No worry about the Japanese clinical development burden.  JEC covers initial clinical development costs and proceeds with all of the tasks all the way to achieve your J-NDA.  Also, during the clinical development phase, EPS, the pioneer of Japanese CRO, supports and collaborates with SKK for local clinical trials.  JEC offers to recover these clinical development burdens only after getting marketing authorization. Plus, you do not need to set up physical presence in Japan.  This is the heart of the JEC opportunity for US and European companies.  Now is the time to re-evaluate the Japanese MarketIf you have thought about Japanese market entry or have previously tried to enter the Japanese market but missed the opportunity, let's discuss with us as Japanese patients cannot wait for your asset.  Please feel free to contact us to learn more. About SANWA KAGAKU KENKYUSHO (SKK)SKK is a subsidiary of Suzuken, and the company has full and end-to-end capabilities for pharmaceutical and diagnostic businesses driven by over 800 employees with 70+ years of history in Japan.  About Suzuken GroupSuzuken is one of Japan’s leading pharmaceutical wholesalers with 2,386 billion yen (about 15.7 billion USD) sales and 13,000+ employees as of March 2024. Notably, Suzuken has extensive knowledge and know-how for the distribution of rare disease drugs.  About Bushu PharmaceuticalsBushu Pharma is a Japan-based CDMO specializing in the production of pharmaceutical products and clinical trial materials.  With 26 years of experience, Bushu supplies products to 56 countries and holds GMP certifications from major regulatory authorities, including Japan, the United States and Europe.  About EPS GroupEPS Group, since 1991, offers comprehensive solutions in drug development, marketing, and healthcare. Leveraging 7,000 employees' expertise, we serve pharmaceutical companies, medical device firms, hospitals, clinics and academia, providing innovative business solutions.

Bushu Pharma's ongoing investments and efforts offer customers state-of-the-art capabilities, increased capacity, and innovative solutions, providing top-tier pharmaceutical manufacturing and supply chain management services. SAN ANTONIO, Dec. 15, 2024 /PRNewswire/ -- Frost & Sullivan researched the contract development and manufacturing organization industry and, based on its analysis, recognizes Bushu Pharmaceuticals (Pharma) with the 2024 APAC Customer Value Leadership Award. The company is a premier contract development and manufacturing organization (CDMO) of pharmaceuticals and medical devices. Renowned for its comprehensive services spanning development to distribution, the company has established itself as a market leader through a strong track record of delivering safe, high-quality products on time and cost-effectively. It leveraged deep domain knowledge, extensive experience, and Good Manufacturing Practices (GMP) certifications from major international regulatory agencies (e.g., United States Food and Drug Administration [FDA], European Medicines Agency, and Pharmaceuticals, and Medical Devices Agency), to establish its robust global presence and supply medicinal products to 56 countries. Continue Reading The company is a premier contract development and manufacturing organization (CDMO) of pharmaceuticals and medical devices. Bushu Pharma offers comprehensive services and cutting-edge capabilities to support customers across the product lifecycle, including development, manufacturing, packaging, quality control, regulatory compliance, and supply chain management. The company utilizes its advanced and wide-ranging manufacturing capabilities, extensive specialized facilities, and highly skilled workforce to produce a broad spectrum of pharmaceutical products, ranging from small molecule drugs to complex biologics (including high potency and sterile products). Bushu Pharma excels in managing complex processes, such as product testing and technical transfer (i.e., it ensures consistency, quality, and regulatory compliance when transferring analytical methods, validation processes, and manufacturing procedures from a client's site to its facilities). Its unmatched capabilities ensure consistent delivery of exceptional quality assurance, on-time delivery, and competitive costs, establishing it as a preferred partner in APAC. Bushu Pharma continues to invest in the latest technologies, introducing automated guided forklifts and humanoid dual-arm collaborative robots to enhance efficiency, boost productivity, and ensure high safety and quality standards. Rubini Kamal, best practices research analyst at Frost & Sullivan, observed, "Bushu Pharma's strategic focus on forging partnerships addresses critical challenges with drug availability and market entry, enhancing its offerings while bridging market gaps and improving healthcare accessibility." Bushu Pharma prioritizes operational excellence and stringent quality control, establishing itself as a secure, trusted manufacturer in the pharmaceutical space. The Bushu Continuity Plan, a resilient and sustainable business system, operates effectively during large-scale disasters and pandemic conditions to ensure continuous production and supply of pharmaceutical products to patients worldwide. Bushu Pharma's facilities, which have temperature and security monitoring systems, ensure that pharmaceutical products are stored and handled optimally to preserve their efficacy and safety. Real-time monitoring also enhances security measures, preventing unauthorized access and safeguarding sensitive materials. Bushu Pharma enhances customer value through robust environmental sustainability measures, including implementing LED lighting with motion sensors, installing solar panels, transitioning to renewable energy, monitoring wastewater quality, and adopting paper trays and biomass films for packaging at its factories. Bushu Pharma's ongoing commitment to retaining customer trust and delivering value is evident in its global client base of over 95 commercial clients, with 50% of them coming from foreign-affiliated clients. Its steadfast commitment to enhancing services, technologies, and expertise positions Bushu Pharma to lead the CDMO sector into its next growth phase, capturing market share and maintaining its leadership in the years to come. "Bushu Pharma's innovative GATEWAY to ASIA services streamline market entry for international clients, while strategic partnerships facilitate efficient product distribution and address regional challenges. The company significantly shortens lead times for entering the Asian market, maintains lean inventory levels, and reduces logistics costs and carbon emissions for global pharmaceutical companies compared to traditional supply chains," added Kamal. Bushu Pharma's commitment to operational excellence, environmental sustainability, and employee engagement solidifies its reputation as a trusted and reliable partner. With its strong overall performance, Bushu Pharma earns Frost & Sullivan's 2024 APAC Customer Value Leadership Award in the contract development and manufacturing organization industry. Each year, Frost & Sullivan presents this award to the company that has demonstrated excellence in implementing strategies that proactively create value for its customers with a focus on improving the return on the investment that customers make in its services or products. The award recognizes the company's unique focus on augmenting the value that its customers receive, beyond simply good customer service, leading to improved customer retention and customer base expansion. Frost & Sullivan Best Practices awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry. About Frost & Sullivan For six decades, Frost & Sullivan has been world-renowned for its role in helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, megatrends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion. Contact us: Start the discussion. Contact: Tarini Singh E: [email protected] SOURCE Frost & Sullivan WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

DUBLIN--( BUSINESS WIRE )--The "Fill Finish Pharmaceutical Contract Manufacturing Market Industry Trends and Global Forecasts to 2035: Distribution by Type of Fill Finish Service Offered, Type of FDF, API Potency, Type of Primary Packaging Container, Scale of Operation and Leading Players" report has been added to ResearchAndMarkets.com's offering. The Fill Finish Pharmaceutical Contract Manufacturing Market is valued at USD 7.2 billion in 2024, growing at a CAGR of 4.8% during the forecast period till 2035. The fill-finish process for small molecules represents the final step in downstream product processing, where the formulated drug is combined with essential excipients and stabilizers. The bulk purified formulation is then transferred into pre-sterilized containers, such as glass vials, prefilled syringes, cartridges, or ampoules for inspection, labeling, and packaging. Recent studies show that small molecule drugs constitute nearly 90% of the current therapeutics pipeline. In 2023, 61% of the 55 FDA-approved drugs were small molecules, reflecting a steady rise from 56% in 2021 and 57% in 2022. Sterile fill-finish is recognized as one of the most critical steps in pharmaceutical production. Aseptic conditions during this stage are essential for ensuring both product quality and patient safety, as well as maintaining the pharmacological effectiveness of the drug. However, the fill-finish process for novel small molecule formulations requires specialized equipment and expertise, driving up production costs. This increase in capital expenditure presents challenges for drug developers with limited resources, pushing many to outsource manufacturing operations to contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs). The growing pipeline of small molecule drugs, their increasing complexity, and the need for specialized expertise is driving demand for fill-finish services in the pharmaceutical industry. Additionally, with a stronger emphasis on quality and multi-product strategies, the adoption of advanced technologies, such as artificial intelligence and robotics, is expected to fuel further investment in this area, promoting growth in the fill-finish pharmaceutical contract manufacturing market. Key Benefits of Buying this Report The report offers valuable insights into revenue estimation for both the overall market and its sub-segments, in order to empower market leaders and newcomers with critical information requisite for establishing their footprint in the industry. The report can be utilized by stakeholders to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies. The report provides stakeholders with a comprehensive view on the Fill Finish Pharmaceutical Contract Manufacturing Market, covering essential information on significant market drivers, barriers, opportunities, and challenges. Key Companies Profiled in the Finish Pharmaceutical Contract Manufacturing Market include: Alcami Amanta Healthcare Aurigene Pharmaceutical Services Batterjee Pharma Burrard Pharmaceuticals Curida Eriochem Fresenius Kabi GlaxoSmithKline Nextar Chempharma Solutions Pfizer CentreOne Plastikon Healthcare Procaps Recipharm ROMMELAG CMO Sharp Sypharma Teva Pharmaceuticals WuXi AppTec Key Topics Covered: 1. PREFACE 2. RESEARCH METHODOLOGY 3. MARKET DYNAMICS 4. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS 4.1. Chapter Overview 4.2. Market Dynamics 5. EXECUTIVE SUMMARY 6. INTRODUCTION 6.1. Chapter Overview 6.2. Introduction to Fill / Finish Services for Small Molecules 6.3. Need for Outsourcing Small Molecules-related Operations 6.4. Role of Contract Manufacturers in the Small Molecules Industry 6.5. Key Considerations while selecting a Fill / Finish Service Provider 6.6. Advantages of Outsourcing Fill / Finish Services 6.7. Risks and Challenges of Outsourcing Fill / Finish Operations 6.8. Future Perspectives 7. MARKET LANDSCAPE 7.1. Chapter Overview 7.2. Small Molecules Fill / Finish Service Providers: Overall Market Landscape 8. COMPANY PROFILES: SERVICE PROVIDERS IN NORTH AMERICA 8.1. Chapter Overview 8.2. Leading Small Molecules Fill / Finish Service Providers based in North America 8.2.1. Alcami 8.2.2. Pfizer CentreOne 8.2.3. Sharp Services 8.3. Other Leading Small Molecules Fill / Finish Service Providers based in North America 8.3.1. Burrard Pharmaceuticals 8.3.2. Plastikon Healthcare 9. COMPANY PROFILES: SERVICE PROVIDERS IN EUROPE 9.1. Chapter Overview 9.2. Leading Small Molecules Fill / Finish Service Providers based in Europe 9.2.1. Fresenius Kabi 9.2.2. GlaxoSmithKline 9.2.3. Recipharm 9.3. Other Leading Small Molecules Fill / Finish Service Providers based in Europe 9.3.1. Curida 9.3.2. ROMMELAG CMO 10. COMPANY PROFILES: SERVICE PROVIDERS IN ASIA-PACIFIC 10.1. Chapter Overview 10.2. Leading Small Molecules Fill / Finish Service Providers based in Asia-Pacific 10.2.1. Aurigene Pharmaceutical Services 10.2.2. Sypharma 10.2.3. WuXi AppTec 10.3. Other Small Molecules Fill / Finish Service Providers based in Asia-Pacific 10.3.1. Amanta Healthcare 11. COMPANY PROFILES: SERVICE PROVIDERS IN THE REST OF THE WORLD 11.1. Chapter Overview 11.2. Leading Small Molecules Fill / Finish Service Providers based in the Rest of the World 11.2.1. Eriochem 11.2.2. Teva Pharmaceutical Industries 11.3. Other Small Molecules Fill / Finish Service Providers based in Rest of the World 11.3.1. Batterjee Pharma 11.3.2. Procaps 12. COMPANY COMPETITIVENESS ANALYSIS 12.1. Chapter Overview 12.2. Assumptions and Key Parameters 12.3. Methodology 12.4. Small Molecules Fill / Finish Service Providers based in North America 12.5. Small Molecules Fill / Finish Service Providers based in Europe 12.6. Small Molecules Fill / Finish Service Providers based in Asia-Pacific and Rest of the World 13. CAPACITY ANALYSIS 13.1. Chapter Overview 13.2. Global Annual Small Molecules Fill / Finish Capacity for Ampoules (Number of Units) 13.3. Global Annual Small Molecules Fill / Finish Capacity for Cartridges (Number of Units) 13.4. Global Annual Small Molecules Fill / Finish Capacity for Prefilled Syringes (Number of Units) 13.5. Global Annual Small Molecules Fill / Finish Capacity for Vials (Number of Units) 14. CASE STUDY: ROBOTIC SYSTEMS IN FILL / FINISH OPERATIONS 14.1. Chapter Overview 14.2. Role of Robotic Systems in Fill / Finish Operations 14.3. Companies Providing Robots for use in the Pharmaceutical Industry 14.4. Companies Providing Isolator-based Aseptic Filling Systems 14.5. Small Molecules Fill / Finish Service Providers: List of Equipment Used 14.6. Concluding Remarks 15. CASE STUDY: READY-TO-USE PACKAGING COMPONENTS FOR ASEPTIC FILL / FINISH 15.1. Chapter Overview 15.2. Role of Ready-to-Use Packaging Components in Aseptic Fill / Finish Operations 15.2.1. Advantages of Ready-to-Use Packaging Components 15.2.2. Disadvantages of Ready-to-Use Packaging Components 15.3. Companies Providing Ready-to-Use Packaging Components 15.4. Concluding Remarks 16. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES 16.1. Chapter Overview 16.2. Market Drivers 16.3. Market Restraints 16.4. Market Opportunities 16.5. Market Challenges 16.6. Conclusion 17. GLOBAL PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET 17.1. Chapter Overview 17.2. Assumptions and Methodology 17.3. Global Pharmaceutical Fill / Finish Manufacturing Market, till 2035 17.3.1. Scenario Analysis 17.3.1.1. Conservative Scenario 17.3.1.2. Optimistic Scenario 17.4. Key Market Segmentations 18. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY TYPE OF FILL / FINISH SERVICE OFFERED 18.1. Chapter Overview 18.2. Assumptions and Methodology 18.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Type of Fill / Finish Service Offered, 2019, Current Year and 2035 18.3.1. Pharmaceutical Fill / Finish Manufacturing Market for Terminal Sterilization, till 2035 18.3.2. Pharmaceutical Fill / Finish Manufacturing Market for Aseptic Filling, till 2035 18.3.3. Pharmaceutical Fill / Finish Manufacturing Market for Blow-Fill-Seal, till 2035 18.4. Pharmaceutical Fill / Finish Manufacturing Market, by Type of Fill / Finish Services Offered: Market Dynamics Assessment 18.4.1. Penetration-Growth (P-G) Matrix 18.4.2. Data Triangulation and Validation 19. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY TYPE OF FDF 19.1. Chapter Overview 19.2. Assumptions and Methodology 19.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Type of FDF, 2019, Current Year and 2035 19.3.1. Pharmaceutical Fill / Finish Manufacturing Market for Generic FDF, till 2035 19.3.2. Pharmaceutical Fill / Finish Manufacturing Market for Originator FDF, till 2035 19.4. Pharmaceutical Fill / Finish Manufacturing Market, by Type of FDF: Market Dynamics Assessment 19.4.1. Penetration-Growth (P-G) Matrix 19.4.2. Data Triangulation and Validation 20. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY API POTENCY 20.1. Chapter Overview 20.2. Assumptions and Methodology 20.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by API Potency, 2019, Current Year and 2035 20.4. Pharmaceutical Fill / Finish Manufacturing Market, by API Potency: Market Dynamics Assessment 21. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY TYPE OF PRIMARY PACKAGING CONTAINER 21.1. Chapter Overview 21.2. Assumptions and Methodology 21.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Type of Primary Packaging Container, 2019, Current Year and 2035 21.4. Pharmaceutical Fill / Finish Manufacturing Market, by Type of Primary Packaging Container: Market Dynamics Assessment 22. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY SCALE OF OPERATION 22.1. Chapter Overview 22.2. Assumptions and Methodology 22.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Scale of Operation, 2019, Current Year and 2035 22.4. Pharmaceutical Fill / Finish Manufacturing Market, by Scale of Operation: Market Dynamics Assessment 23. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY COMPANY SIZE 23.1. Chapter Overview 23.2. Assumptions and Methodology 23.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Company Size, 2019, Current Year and 2035 23.4. Pharmaceutical Fill / Finish Manufacturing Market, by Company Size: Market Dynamics Assessment 24. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY GEOGRAPHICAL REGIONS 24.1. Chapter Overview 24.2. Assumptions and Methodology 24.3. Pharmaceutical Fill / Finish Manufacturing Market: Distribution by Geographical Regions, 2019, Current Year and 2035 24.4. Pharmaceutical Fill / Finish Manufacturing Market, by Geographical Regions: Market Dynamics Assessment 25. PHARMACEUTICAL FILL / FINISH MANUFACTURING MARKET, BY LEADING PLAYERS 25.1. Chapter Overview 25.2. Leading Industry Players 26. CONCLUSION 27. EXECUTIVE INSIGHT 27.1 Chapter Overview 27.2. Bushu Pharmaceuticals 27.2.1. Company Snapshot 27.2.2. Interview Transcript: Tomoya Sato, Senior Executive Director, Global Sales and Marketing 28. APPENDIX I: TABULATED DATA 29. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS For more information about this report visit https://www.researchandmarkets.com/r/xrtxqg About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.