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DSM Sinochem Pharmaceuticals launches Atorvastatin film-coated tablets, expanding its finished dosage statins portfolio

(June 18, 2018)

Rijswijk, 18 June 2018, June 18, 2018 (GLOBE NEWSWIRE) --
Building upon its first generic finished dosage statin launch (Rosuvastatin) in January of this year, DSM Sinochem Pharmaceuticals  (DSP) has this month released its fully backward-integrated, generic Atorvastatin drug product within the EU. Additional markets are scheduled to follow later in the year.Atorvastatin is used primarily in the prevention of cardiovascular disease and hyperlipidemia, commonly known as high cholesterol, the number one cause of death worldwide. Currently, statins are the most prescribed drug family globally in the fight against these potentially life-threatening conditions.

 

Expanding statins portfolio

With the launch now of Atorvastatin finished dosage formulation, coming on the heels of the successful launch of Rosuvastatin in January of 2018, DSP is actively expanding its statins drug product portfolio, realizing its aspiration of becoming a full-service generics pharmaceutical company. What sets DSP apart from competitors is its backward integration and secure control of its supply chain in the production of its finished drug products.

 

In 2012, DSP was the first pharmaceutical manufacturer worldwide to offer generic Atorvastatin active pharmaceutical ingredients (APIs) under a Certificate of Suitability (CEP).  Since 2014, DSP has produced enzymatic Atorvastatin API in its state-of-the-art facility in Toansa, India for third party customers, as well as now for its own new finished dosage formulation.

 

BU Director for Drug Products, Lucas Wiarda stated: “In utilizing our own in-house APIs to develop our finished dosage Atorvastatin, we deliver to both existing and future customers a product that offers unparalleled reliability.  Customers can trust that DSP’s Atorvastatin is comprised of APIs from our own supply chain, which were first developed back in 2012.  Our statins portfolio now contains the two most popular products in the fight against cardiovascular disease and high cholesterol, and showcases our commitment to providing outstanding generic statins in this highly-competitive market.”

 

In bringing Atorvastatin finished dosage formulation to the marketplace, DSP continues to deliver on its brand promise to customers, with Quality via world-class, differentiated active pharmaceutical ingredients, Reliability through an internal supply chain for all elements of producing a finished dosage product, and Sustainability at the forefront of its drug product production, using patented enzymatic technology which ensures an unmatched eco-friendly production process.

 

DSP holds an electronic Common Technical Document (eCTD) dossier for Atorvastatin finished dosage formulations (in 10, 20, 40, and 80 mg film-coated tablets, along with additional 30 and 60 mg strengths complementing the standard dosage range) suitable for climate Zone II (Mediterranean and subtropical zone), with a 24-month shelf life.  DSP is currently pursuing further stability studies to expand its filings to additional climate zones.

 

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About DSM Sinochem Pharmaceuticals

 

DSM Sinochem Pharmaceuticals (DSP) is the global leader in sustainable antibiotics, next-generation statins and anti-fungals. DSP develops, produces and sells intermediates, active pharmaceutical ingredients and drug products. Our employees worldwide work together to deliver cutting-edge generics solutions that help to keep customers ahead of the competition.

 

Headquartered in Singapore, the group has manufacturing sites and sales offices in China, India, Egypt, the Netherlands, Spain, the USA and Mexico. DSP is a 50/50 Joint Venture of Royal DSM, a global science-based company active in health, nutrition and materials, and Sinochem Group, a Fortune 500 enterprise.

 

For more information please visit www.dsm-sinochem.com or contact DSM Sinochem Pharmaceuticals Corporate Communications, Geoff Vokes, Senior External Communications Manager. E-Mail: [email protected]

 

CONTACT: Geoff VokesDSM Sinochem [email protected]

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