Finished dosage formulation of Rosuvastatin successfully launched

Published: 15-Jan-2018

DSM Sinochem Pharmaceutical (DSP) has successfully launched its fully backward integrated, generic Rosuvastatin drug product in multiple Western European countries, the launch will be extended to additional countries before the end of January

After being one of the first companies globally to receive a CEP in early 2016 for Rosuvastatin API, DSP was again 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.

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 costs for quality assurance and testing, because of 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.

Karl Rotthier, CEO at DSP, said: “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.”

Lucas Wiarda, BU Director Drug Products at DSP, said: “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.”

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