By: DSM Pharma Solutions Editors
Currently, DSM is the first and only company in the world that can provide access to US Drug Master Files, Japanese Drug Master Files and Certificates of Suitability (CEP) for all 13 vitamins. What does it take to stay on top of this dynamic market environment?
At DSM, we are truly passionate about our ability to remain agile in challenging and dynamic market environments. First and foremost, there is an established long-term commitment from senior leadership to continue to deploy capital via significant investments in our pharma business. To date, this has resulted in the implementation of dedicated global and local pharma teams with presence across key markets, the development of the highest quality standards in compliance with the relevant laws and regulations, and the scale and sustainability required to meet customer demand. We also continue to develop our pharma capabilities; for example, our pharma pre-mix site in Colombia was recently successfully inspected by LATAM authorities. This further reinforces our commitment to creating science-based innovations and solutions to improve patients’ lives.
DSM maintains its regulatory and quality expertise, while closely monitoring the regulatory landscape. We aim to take a proactive approach by ensuring our compliance standards stay ahead of current industry requirements. With a strong global and regional presence, DSM supports customers with registration globally and in key markets such as US, Japan, EU, Brazil, Russia, Egypt and India. DSM is also an active long-term member of a variety of industry associations, which allows us to maintain close contact with the authorities while remaining actively involved in the monograph and regulation review processes.
Can you provide any specific examples?
The recent concerns around the presence of nitrosamines in a variety of pharmaceutical compounds has presented challenges across the pharmaceutical industry. For DSM, this was an opportunity to showcase our agile business model to quickly and efficiently adjust to new regulatory requirements. DSM processed nitrosamine assessments across our entire API and excipient portfolio (over 150 ingredients) ahead of schedule and well within the six-month timeline, thereby enabling our customers to also meet their intended timelines. This was a complex multifunctional undertaking (e.g. quality, toxicology, R&D, regulatory) requiring close collaboration and operational synergy in order to achieve a successful outcome.
Sustainability, reliability of supply and consistent product quality are foundational elements of the DSM mission. Since 2010, DSM has invested significantly to develop best-in-class GMP facilities, sustaining the foundation for an industry-leading global network of API manufacturing plants. For instance, at our Dalry, UK site, we’ve reduced emissions and energy usage by over 50 percent since 2008. Eighty-seven percent of waste is recycled here, resulting in an exceedingly efficient and environmentally responsible use of resources. Our global supply chain enables us to ensure production is maintained at the highest quality, especially in business-critical circumstances.
What are the mechanisms in place to keep up with high industry standards?
DSM opens its doors every day to a variety of key stakeholders. We are continuously inspected by the regulatory authorities, customers and validated third-party auditors and remain actively engaged with industry associations in order to maintain the highest quality certifications. All pharma products are produced according to appropriate GMP standards and are closely supervised and controlled by relevant internal audit programs and quality systems (e.g. Code of Business Conduct).
What specific API-related services does DSM offer its customers?
DSM brings expertise and innovation to co-develop new over-the-counter products and prescription medicines in this ever changing and competitive marketplace. We also realize the importance of continued success after launch, so we support the growth and evolution of these products across their entire lifecycle. Our 400-strong R&D team; portfolio of patents; global network of regulatory specialists; and key scientific, academic, and manufacturing partnerships provide the foundational capabilities for timely and effective product co-innovation.
Quality is far-reaching and extends beyond regulatory and industry standards. What does that mean for DSM customers?
At DSM, our commitment to quality extends broadly and is represented by our investments in eco-friendly technologies, as well as patient-centric approach to innovation. DSM teams are highly aware of – and sensitive to – the fact that the products we produce reach the most vulnerable population groups (i.e. patients with severe conditions and multiple co-morbidities, from infants to the elderly). The stakeholder experience is at the core of our business approach; working with the patient in mind is how we internally guide our ways of working across all business functions, from quality, regulatory all the way to production and innovation. And as a purpose-led partner, DSM actively supports research related to COVID-19.
Why partner with DSM? We help both brand and generic manufacturers realize market success by enabling agile drug development, ensuring seamless product entry and optimizing life-cycle management efforts. We deliver passion, innovation, and scientific expertise for every stage of your products’ life cycle. You will have access to our broad portfolio of APIs, customized solutions, and expert services globally. DSM has more than 70 years of experience in producing and securing the supply of APIs. This, together with the unique innovation expertise and the unparalleled ability to manage the market entry registration process make us a most ideal partner for the development of over-the-counter products and prescription medications. This takes more than active pharmaceutical ingredients. It takes a partner.
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19 June 2020
7 min read
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