Singapore-headquartered DSM Sinochem Pharmaceuticals (DSP) develops, produces and sells intermediates, active pharmaceutical ingredients (API), and drug products.
Atorvastatin is used primarily in the prevention of cardiovascular disease and high cholesterol. The launch of the Atorvastatin finished dosage formulation launch follows DSP’s first generic finished dosage statin launch (Rosuvastatin) in January of 2018.
According to the company, DSP is “actively expanding its statins drug product portfolio” as it looks to become a full-service generics pharmaceutical company.
DSP became the first pharmaceutical manufacturer to offer generic Atorvastatin active pharmaceutical ingredients (APIs) under a certificate of suitability (CEP) in 2012. Since 2014, DSP has manufactured enzymatic Atorvastatin API for third-party customers at its facility in Toansa, India, where it will now produce the new finished dosage formulation.
The company holds an electronic common technical document (eCTD) dossier for Atorvastatin finished dosage formulations suitable for climate Zone II with a 24-month shelf life, and is actively pursuing additional stability studies to expand its filings.