Pharma Action says safety of supply will counter the low costs of Chinese made heparin as it inks a joint venture with the Tönnies Group.
Pharma Action supplies the active pharmaceutical ingredient (API) heparin to a mixture of customers and this venture will ensure a stream of the raw ingredient mucosa, with fellow German firm the Tönnies Group set to process in excess of 30 % of Europe’s supply from a new facility in Rheda-Wiedenbrueck, scheduled to open in 2014.
“At present part of the total mucosa quantities from Tönnies are being sold to major players in the market,” Pharma Action founder and manager Erol Isim told in-Pharmatechnologist.com, “but these will be utilized 100% in-house by Pharma Action once the crude Heparin factory is fully operative.”
Mucosa is processed from pigs via hydrolysis, he added, with the next step being the purification of the material into heparin which is used for the prevention and treatment of thrombosis and embolisms as well as for the treatment of heart disease.
Safety of Supply
According to the company most heparin is currently produced in China with the various sources used having been known to compromise safety in the past. The firm may well be alluding to the 2008 scandal when a contaminated batch manufactured in China led to hundreds of adverse reactions in the US and, according to the New York Times , 81 deaths.
Therefore the sourcing of mucosa solely from Tönnies’ new facility for processing at Pharma Action’s Berlin plant - recently expanded to cope to manage annual crude heparin output in excess of ten metric tonnes as of next year - will help ensure the safety of the supply.
“Pharma Action has developed the most advanced and efficient production process for both crude and API production,” Isim said, with its control of supply chain giving it the edge on low-cost Chinese manufacturers. “This is our competitive advantage and a true safety aspect.”
He continued: “The backbone of the Chinese Heparin supply chain certainly is more heterogeneously organized with countless crude Heparin manufacturing sites compared to the three slaughterhouses, one crude Heparin factory and one API Heparin factory all operating under current GMP regulations and under one company roof.”