Davipharm, one of the leading domestic manufacturers of high-quality generic drugs, a member of Adamed Group, last week announced the certification of Vietnam’s first high-potency drugs zone for the production of cytotoxic/cytostatic oncological drugs in hard shell capsules, tablets, and coated tablets.
According to new regulations from Vietnam’s Ministry of Health (MoH), as well as guidelines from the World Health Organization, European Medicines Agency, and Pharmaceutical Inspection Co-operation Scheme, the production of certain products containing hazardous substances must be run at separate premises meeting specific criteria.
Michal Wieczorek, CEO of Davipharm said, “The high-potency (HP) zone in Davipharm answers the needs of the MoH, providing high-quality oncological drugs manufactured in Vietnam to Vietnamese patients. It will also increase the role of domestic drug manufacturers in optimising the state budget, improving patient safety, and providing medicines to treat some of the most common diseases in Vietnam.”
He added that currently, eight out of 10 people in Vietnam die from non-communicable diseases (NCDs), including cancers. “This is also why Davipharm decided to be the first domestic drug manufacturer to become a partner of the MoH in the prevention, early detection, and treatment of NCDs in Vietnam. We are proud to support the MoH’s project ‘Vietnamese people giving priority to using Vietnamese drugs’,” Wieczorek said.
Davipharm’s portfolio includes 28 HP drugs, including oncological drugs for breast cancer, leukemia, pancreas, colorectal, stomach, cervix, prostate and lung cancer and for glioblastoma. The company has the capacity to produce batches from 15-100kg with an annual output of 500 million units of HP drugs. The total capacity of the factory is 1.8 billion units a year. In 2017 Polish pharmaceutical and biotechnology company Adamed Pharma acquired a controlling stake in Davipharm, one of the fastest-growing pharmaceutical companies in Vietnam. This is the largest-ever direct private Polish investment in Vietnam.
With over $10 million invested by Adamed by the end of 2020, Davipharm’s production plant in Binh Duong province, Vietnam’s first HP Zone for the production of oncological drugs in solid forms, is an important milestone in terms of high-quality investment. This will be followed by EU-GMP certification later this year as a continuation of the company strategy focused on raising the standards of drug production.