Zhejiang Juhua has announced that the US FDA accepted a drug master file (DMF) for pharmaceutical-grade HFA 134a submitted by its fluorochemicals subsidiary on December 26, 2014 and that the company also received accreditation for a drug registration certificate from the CFDA on February 15, 2015, representing the culmination of a 7-year registration process.
According to Juhua, it signed a contract for the product with a pharmaceutical company outside of China in February 2015 and has received inquiries from a number of domestic pharmaceutical companies.
The company said, “The two certificates represent the product of Juhua HFA-134a/P has the legitimate qualification to be used as aerosol propellents instead of CFC MDIs in medical uses. The success of registration mark a milestone for Juhua HFA-134a to be extented to domestic and oversea pharmacy market, a big step from Industrial-grade refrigerants to pharmaceutical chemicals, it is also a symbol for Juhua’s product go progressively to high-end, streamline and differentiation.”
Juhua Sales Director Wang Sheng added, ‘We know the transition to HFC MDIs is crucial, especially to those MDI manufacturers in Article 5 Parties which ought to complete the CFC phase-out in MDI in 2015 under the Montreal Protocol. To some extent, accelerating the process of HFA-134a/P registration is closely related to national strategy of CFCs phase-out, and we are ready to meet customer needs and market demand”
The HFA-134a/P is available for sale on Chinese e-commerce site Alibaba.com. According to the Juhua website, the propellant is available in 400, 800, 926, and 1,000 L tanks, as well as tank cars.
