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Commercial API Services & Supply

Your Commercial API
manufacturing services

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CARBOGEN AMCIS has been setting the standard in commercial API manufacturing since 1996. Commercial API manufacturing includes the wide range of services associated with the development, manufacture and supply of active pharmaceutical ingredients (APIs) in marketed products.

  • Flawless track record with zero product recalls
  • Successfully commercialized over 30 proprietary products by respecting the stringent requirements of all of the major global markets
  • Specialized with High Potency commercial products
  • 1-3 new Process Performance Qualification (PPQ) campaigns each year, including for new High Potency (HiPo) APIs
  • Regular support to our customers with their New Drug Applications (NDAs)
  • Experienced Regulatory Affairs department to assist clients through the submission process and maintaining regulatory files throughout the post-approval lifecycle

Life cycle management

Life Cycle Management is a strategic imperative for pharmaceutical companies, ensuring a drug remains competitive, profitable, and compliant across its market lifecycle.

CARBOGEN AMCIS maintains the competitiveness and longevity of pharmaceutical products within a dynamic marketplace through its ability to offer the most comprehensive life cycle management services. As part of Dishman Carbogen Amcis Group, we have transferred over 15 processes to the UK, India, and China with a 100 percent success rate in the past years. These processes include raw starting materials (RSM), intermediates, and the marketed active pharmaceutical ingredient (API). This capability is underpinned by continuous verification and monitoring of process performance using statistical data, to ensure the highest standards of quality and efficiency.

CARBOGEN AMCIS also leverages the Group’s global footprint to provide increased capacity, access to a lower cost base, and expertise in large-scale process optimization to drive the continuous evaluation and implementation of process improvements. This life cycle management approach includes the provision of alternative synthetic pathways, including second-generation processes, and the skilled management of the transition to off-patent supply to ensure sustained product success and market leadership.

Supply chain risk management

At CARBOGEN AMCIS, we offer process development and scale-up capabilities, drawing on over 40 years of pioneering experience in process research and development.
Our Experience
Since 2014, CARBOGEN AMCIS has been at the forefront of implementing robust Business Continuity Plans (BCP) and Business Continuity Management (BCM), tailored to critical processes and infrastructure. This proactive approach ensures that we not only keep pace with the global market and clients demands, but also anticipate and prepare for future challenges.
Risk Mitigation
Recognizing that risk mitigation is critical is at the core of our strategy. Whether natural disasters, cyber-attacks or economic downturns, our comprehensive business continuity plans are designed to address the unexpected. These plans are not just theoretical frameworks. They are practical, actionable guides that have been put to the test to ensure the resilience and continuity of our operations under adverse conditions.
Protecting Investments
Through careful planning and preparation, we can protect our stakeholders' investments, minimize financial losses and safeguard corporate reputation in times of crisis. Financial robustness is the foundation of our ability to withstand and quickly recover from disruptive events. With the support of a strong pool of banks, CARBOGEN AMCIS has the financial stability and reliability that is essential for sustainable operations and long-term partnerships.
Compliance and Regulations
Our business continuity plan (BCP) is designed to meet stringent regulatory and industry standards and is not just about complying, but about achieving operational excellence. Rigorous auditing and continuous improvement practices support this commitment to compliance. This ensures our services meet the highest levels of quality and security.
Geographical Footprint
CARBOGEN AMCIS' geographic footprint, with locations in multiple countries, enhances our ability to provide a broad perspective and maintain commitment through independent locations around the world. This international presence enhances our understanding of regional risks and regulatory environments. As a result, we can provide more resilient and adaptable drug substance supply chain solutions.
Long-term Strategy
Our clients and customers can rely on us to understand the long-term strategy and specific components of our Business Continuity Plan (BCP). From crisis communication procedures to data backup and recovery strategies, we are able to provide you with a detailed insight into how we will protect your investment and ensure uninterrupted service delivery. This underscores our unwavering commitment to supporting the needs of our customers and going above and beyond industry standards.

Regulatory affairs & Services for files

At CARBOGEN AMCIS, regulatory services are a cornerstone of our comprehensive pharmaceutical support. They ensure the seamless progress of APIs from development to commercialization and post-approval in all major markets.

Our experienced team has supported the successful launch and supply of more than 30 marketed APIs worldwide. This demonstrates our commitment to excellence and regulatory expertise.

The regulatory affairs service focuses on navigating the complex landscape of pharmaceutical regulations, ensuring that all aspects of developing, manufacturing and distributing of an active substance meet the necessary legal and regulatory standards set by health authorities worldwide, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and others.

A close collaboration between CARBOGEN AMCIS’ Regulatory affairs and the customer streamlines regulatory processes, ensuring compliance and quality. This accelerates new medicines development, benefiting patients and stakeholders.

Guidance through the Development Phases
From preclinical to commercial scale-up, CARBOGEN AMCIS develops customized regulatory strategies to ensure successful submissions. This strategic foresight encompasses all critical aspects, including regulatory input for validation activities and stability studies, helping our clients navigate the regulatory landscape.
Comprehensive Documentation Support
We understand the critical role of documentation. That's why we specialize in preparing Chemistry, Manufacturing, and Controls (CMC) sections for DMF, (A)NDA, MAA, IND and IMPD submissions. Our expertise in producing high quality, eCTD-compliant documentation lays the foundation for successful submissions and facilitates the advancement of projects for future licensing, sales, or funding opportunities.
Integration and Collaboration
Our regulatory services are fully integrated into our day-to-day operations. This ensures that regulatory compliance is maintained throughout development, the commercialization process and the post-approval lifecycle. Fostering an environment of transparency and collaboration, we pride ourselves on our ability to work closely with regulatory agencies when requested by our clients. In addition, we stay at the forefront of regulatory developments and ensure that our practices are always state-of-the-art and fully aligned with current standards through our active participation in industry association groups.

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