New milestone plant certification in Colombia expands Pharma premix opportunities
By: DSM Pharma Solutions Editors
DSM is pleased to announce the ANVISA (Brazilian National Health Surveillance Agency) certification of its Colombian manufacturing plant for the production of pharmaceutical grade vitamin and mineral premixes, granted on 23 November 2020. This announcement follows the previous Good Manufacturing Practice (GMP) certification granted by the National Institute for Food and Drug Surveillance (INVIMA), Colombia's health authority, which authorized the production of both liquid and solid premixes for pharmaceutical applications.
The newly announced ANVISA certification expands commercialization of pharmaceutical premix products into other countries, including Brazil, and represents new opportunities for customers to address growing market demand innovatively and in line with the applicable regulatory and quality standards. Overall, this provides DSM’s partners a competitive advantage by reducing product development time, accelerating the registration and market entry process and enabling patient access. The estimated size of the pharmaceutical market in Latin America in 2023 is USD 76 billion, with an annual growth rate (CAGR) of 7% between 2018 and 2023.1
“The certification of Good Manufacturing Practices issued by ANVISA is an important milestone in the history of DSM in the Latin America region, as it allows us to continue expanding our product portfolio and continue as strategic allies for our customers in the pharmaceutical industry – and now, not just in raw materials, but in products with higher added value through our premixes,” said Eduardo Debiagi, Latin America Operations Director at DSM. “Today, more than ever, this sector requires strong partnerships due to the situation we live in, where greater demands for products already on the market are required and higher agility in innovations and launches that will positively impact people's health.”
For Giovani Saggioro, Business Director for the Specialized Nutrition line in Latin America, DSM's commitment is to provide customers and partners with the opportunity to develop products based on vitamins and minerals with pharmaceutical grade, satisfying an increasing demand from consumers and healthcare professionals. "Our complete portfolio of APIs is unique worldwide and now, with the recent certification of the premix line, we will offer our pharmaceutical customers another option to accelerate the launch of new products."
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Emerging scientific research continues to highlight the beneficial impact of therapeutic, high-dose vitamin intake (i.e. above and beyond nutritional requirements) to complement the treatment on a variety of chronic illnesses, such as diabetes mellitus, cancer, multiple sclerosis, cardiovascular disease, non-alcoholic fatty liver disease and Alzheimer’s disease. According to the World Health Organization, six of the top ten causes of death worldwide represent chronic non-communicable diseases, such as ischemic heart disease, diabetes mellitus and dementia.2 By 2045, an estimated 548 million people will be living with diabetes, a projected increase of 51%.3 Many of these diseases disproportionately affect developing economies and groups of patients with significant unmet needs, further reinforcing the need to explore innovative and evidence-based treatments.
With over 70 years of experience in pharmaceutical applications, DSM helps both brand and generic manufacturers realize market success through facilitating agile drug development, ensuring seamless product entry, enabling significant growth, and optimizing life-cycle management. DSM’s 400-strong R&D team and global network of regulatory specialists provide the foundation for a full suite of end-to-end service offerings.
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 IQVIA Market Prognosis Issue March 2019.
 World Health Organization: Top 10 causes of death, October 2018 (http://www.who.int/gho/mortality_burden_disease/causes_death/top_10/en/).
 P. Saeedi et al. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract 2019;157:843-52.