CASE STUDY
Fette Compacting and Hisun Pharmaceutical achieve the impossible
Subsequent to receiving an order for a P2020 tablet compacting machine on 23 March, it took Fette Compacting China less than one month to complete the machine delivery, installation and training at Hisun Pharmaceutical. As a result, it’s made a significant contribution to ramping up Favipiravir production in China to help fight COVID-19.
I
n all areas of the world, the global COVID-19 pandemic has seen the pharma industry refocus on epidemic prevention and control of the infection. The World Health Organization (WHO) is sparing no effort to call on all nations to strengthen unity and cooperation to fight the virus and prevent its spread. The scientific world is unrelenting in its search for a vaccine, while continuing investigations on how to treat patients. This global approach has significantly accelerated the development of therapeutic drugs for the treatment of COVID-19. Zhejiang Hisun Pharmaceutical Co. (Hisun) is a leading pharmaceutical manufacturing company in China. During clinical trials in the early phase of the outbreak in China, Hisun’s oral solid dosage drug Favipiravir showed positive effects in the treatment of patients and good clinical efficacy with no significant side effects. The antiviral agent Favipiravir, originally developed for the treatment of flu, was approved for manufacturing and marketing in Japan in March 2014, under the trade name Avigan. The clinical trials in Shenzhen and Wuhan showed that Favipiravir can help to shorten the recovery time for mild and middle-severe COVID-19 infection cases. Furthermore, a positive effect of shortening the fever duration of infected patients was observed. On 15 February 2020, the Chinese Food and Drug Administration (CFDA) officially approved Favipiravir as the first drug with potential efficacy in the treatment of COVID-19 and it’s now recommended for guided treatment programmes in China. Even if not formally approved by health authorities in Europe or the US, and in the absence of an effective and widely used vaccine to treat COVID-19 anywhere in the
40
JULY 2020 // WWW.PHARMACOS.CO.ZA
Did you know? Fette Compacting’s premises in China
world, countries such as Italy have also approved the use of the drug.
MANUFACTURING THE FIRST BATCH Amid the epidemic situation and after the formal CFDA approval, the setting up of mass production became a race against the clock. With time-to-market being of the essence, Hisun, together with the involved authorities, initiated common steered efforts to ensure the production of Favipiravir within the required quality and safety measures. A unique and elite task force was formed, consisting of market supervision authorities from the region, GMP inspectors and Hisun’s experts, to track and supervise the entire process of the first Favipiravir tablet batch production from the raw materials to the finished drug. The task force team worked around the clock to guide the standard production of the drug. Hisun’s pharmaceutical experts worked closely with the drug supervisors 24/7 in an effort to overcome multiple challenges, such
All Favipiravir tablets in China are manufactured by Hisun. As the situation with the disease is improving, the medication has been sold through omnichannel across China. It has also been used to support over 30 countries and regions in the fight against COVID-19. as epidemic control-related traffic control limitations and staff shortages. After the initial production commenced on 16 February, the first 22 transport cartons of Favipiravir were completed on 18 February, designated for hospitals in Wuhan and contributing to the treatment of COVID-19 in the Chinese epicentre of the outbreak. Coordinated by the joint prevention and control mechanism of the State Council of the People’s Republic of China (PRC State Council), Hisun has since provided drug support to many countries after the epidemic rose to pandemic status with the worldwide spread of the infection. For its great achievements in such a short period, Hisun was also acknowledged by the PRC State Council. Although tremendous, it became clear the actual Favipiravir production output would have been far too low to cover
