The award, which follows an inspection by the European Medicines Agency (EMEA) in May, applies to both liquid and lyophilised cancer drugs produced at Venus’ facility in Baddi in Himachal Pradesh.
The plant, which is also compliant with good manufacturing practice (GMP) standards set out by the World Health Organisation (WHO) and health bodies in countries including Latin America, Zimbabwe, Uganda and the Ukraine, is capable of producing around 10m vials of oncological drugs a year.
Venus said that the EMEA award will allow it to ramp up its targeting of European drugmakers, building upon the existing relationships it has established through its German subsidiary and manufacturing facilities.
The firm added that with the global market for cancer drugs expected to grow 30 per cent a year, the ability to work with pharmaceutical companies in Europe and elsewhere had “cleared the path [for] its international foray in oncology for regulated markets in a big way.”
Venus is also currently working on site transfer projects with companies in both Australia and Canada, specifically focussed on expanding the production of its range of cancer medications.
Additionally in April, Venus received accreditation from the General Foreign Trade Organisation (GFTO) of Syria, enabling it to begin targeting potential manufacturing clients in this emerging market and providing a further demonstration of the company’s ambitions on the global stage.
Tobracef launched in India
In related news, Venus announced the launch of its anti-infective Tobracef, a fixed dose combination of cephalosporin and aminoglycoside, in its home territory.
The firm explained that the drug, which successfully completed Phase III clinical assessment in March, has been designed to treat patients suffering from cystic fibrosis (CF) associated with acute pulmonary exacerbation (APE).
It also claimed that the product represents one of the few new and effective therapies for methicillin resistant Staphylococcus aureus (MRSA) infection, rates of which are continuing to increase globally.
Venus said that it is initially targeting India’s CF market, which generated around INR 2bn ($47m) in revenue each year. It also said that it hopes that Tobracef can become the country’s leading branded product for this indication within the next two years.
The firm added that it has filed patent applications for the drug in approximately 50 countries worldwide and is currently in talks with potential licensing partners in the US and other strictly regulated markets.