After being one of the first companies globally to receive a CEP in early 2016 for Rosuvastatin API, DSP again proves to be a frontrunner by being one of the first to launch Rosuvastatin drug products in Western Europe using its in-house produced API.
Statins are currently the most prescribed drug class globally for high cholesterol and cardiovascular diseases and are among the top selling drugs worldwide. Rosuvastatin is used for reducing high cholesterol and preventing cardiovascular disease, which is the number one cause of death worldwide.
Quality, Reliability and Sustainability
In line with its brand promise of Quality, Reliability and Sustainability, DSP’s Rosuvastatin offers customers superior performance in all three areas. For its finished dosage formulations, DSP uses its own in-house manufactured API. This proprietary, backward integrated, process, which is protected by 10 patent families, involves a highly efficient enzymatic coupling step, and offers customers independence from third party intermediate suppliers. Additional advantages to its API include unrivalled product quality with an assay of >99% and large batch sizes of 200 kg. This further results in significantly reduced Quality Assurance and testing costs, the absence of hazardous residual chemicals and a 35% reduced carbon footprint related to production.
With the successful launch of the Rosuvastatin finished dosage formulation, on top of the earlier successful launch of DSP’s beta lactam drug products, and the upcoming launch of Atorvastatin in Europe by summer 2018, the company is quickly expanding its drug product portfolio. What sets DSP apart from competitors is its backward integration and full control of its supply chain.
CEO, Karl Rotthier: “I am proud that our company, together with our partners, is among the first worldwide to launch a generic Rosuvastatin finished dosage formulation in Western Europe upon patent expiration; after being one of the first to offer the Rosuvastatin API under CEP. This shows our dedication to excellence and our aspiration to continue to be an industry leader”.
BU Director Drug Products, Lucas Wiarda: “As with every one of our products, Rosuvastatin delivers superior performance on quality, reliability and sustainability compared to the industry average. This is largely due to DSP’s full control of its manufacturing process from start to finish. Building on our strong position in beta lactams, Rosuvastatin is an excellent addition to our drug products portfolio which we proudly offer to our customers.”
Currently DSP holds an eCTD dossier for Rosuvastatin finished dosage formulations (5,10,20 & 40mg FCT) containing Zone II & IV stability data and a 36 month shelf life.
For more information please visit www.dsm-sinochem.com
DSM Sinochem Pharmaceuticals Corporate Communications
Erin van Wijngaarden
Manager PR & Corporate Communications.