Centrient Pharmaceuticals, a specialist in sustainable antibiotics, next-generation statins, and anti-fungals, has started production at its new statins manufacturing unit. With the building of its second dedicated unit on the Toansa site in India now completed, the company will double its statins production capacity.
This will enable Centrient to meet growing demand for its sustainably manufactured Atorvastatin and Rosuvastatin active pharmaceutical ingredients (APIs).
The facility incorporates design features that allow further improvements in GMP and energy utilisation, and enable greater automation
Ground breaking of the new manufacturing unit started at the end of 2019 and commercial supplies from the new unit will start in mid-2021. With the new manufacturing line being operational and doubling the production capacity, Centrient will be even better positioned to secure supply.
"We are extremely proud that we have been able to complete this project in a timely way given the challenges of executing such a complex project in the midst of the COVID pandemic," said Jim McPherson, Chief Quality & Technical Operations Officer. "The facility incorporates design features that allow further improvements in GMP and energy utilisation, and enable greater automation for improved process control."
The news of the facility expansion follows major milestones on statins that the company reached in the past years. In 2012, under the name of DSM Sinochem Pharmaceuticals, it was the first pharmaceutical manufacturer worldwide to offer generic Atorvastatin APIs under a Certificate of Suitability to the Monograph of the European Pharmacopoeia (CEP).
Since 2014, it has produced the unique Atorvastatin APIs in its state-of-the-art facility in Toansa, India for third-party customers.
Statins market
Statins are currently the most prescribed drug class globally for the treatment of high cholesterol and cardiovascular diseases and are among the top-selling drugs worldwide. The markets for Atorvastatin and Rosuvastatin in particular, have shown steady growth in the past years, as a result of the continued global prevalence of high cholesterol issues, replacement of older generation statins, and genericisation of the market.
Being backward integrated, Centrient is independent from external imports of starting materials. Its enzymatic route of synthesis and patented technology minimise the use of harmful solvents, generate less waste, and reduce the company’s carbon footprint by 32% as compared to traditional manufacturers.