Sinovac’s fill and pack plant gets SFDA GMP nod
Sinovax’ international development officer Alan Meng told in-PharmaTechnologist that certification for the facility, which employs 85 people, will help the firm meet growing demand for products like the hepatitis vaccines Healive and Bilive and its seasonal human influenza product Anflu.
He added that facility’s good manufacturing practice (GMP) status will allow it to become a production hub for its H5N1 pandemic influenza vaccine Panflu, which is included in China’s prevention and control strategy.
Meng went on to say that: “Currently, all of products produced at the new filling and packaging plant are sold in the domestic market of China. Although we are seeking opportunities to export our products, we focus on developing countries and regions at this moment.
“Generally speaking, the Chinese drug regulatory system is getting strict. One of most significant changes is the launch of Chinese batch release regulation in 2006. According to the regulation all vaccines sold in China have to pass quality check that conducted by regulatory body independently.”
He explained that while Sinovac’s focus on the domestic vaccine market means it has not sought GMP accreditation from regulators in other countries, the firm maintains all its manufacturing and filling facilities to international standards, including a fully documented quality assurance plan.
In a press statement, Sinovac CEO Weidong Yin said: ''Receipt of the GMP certification and the operation of the state-of-the-art filling and packaging facility provide the foundation for the further development of Sinovac. We are well positioned to increase output to meet increasing market demand and ultimately achieve sales growth.”
As part of its growth plan Sinovac is developing a universal pandemic influenza vaccine and a product to combat Japanese encephalitis. In addition, its subsidiary Tangshan Yian is working on an in-activated animal rabies vaccine for the Chinese domestic market.
