Hyderabad-based pharmaceutical company Hetero has entered into an agreement with Gilead Sciences Inc. for the manufacture and distribution of a potential coronavirus therapy Remdesivir.
Hyderabad-based pharmaceutical company Hetero has entered into an agreement with Gilead Sciences Inc. for the manufacture and distribution of a potential coronavirus therapy Remdesivir. A leading producer of anti-retroviral drugs, Hetero can now distribute Remdesivir in 127 countries, including India. Remdesivir is an investigational drug which has received emergency use authorisation (EUA) from the US Food and Drug Administration (USFDA) to be administered to hospitalised patients with severe coronavirus infection. Hetero has developed a fully integrated supply chain for the product, B.Partha Saradhi Reddy, chairman of Hetero Group, said on Wednesday. Hetero was already working with the government, ICMR and DCGI for necessary studies and approvals to bring Remdesivir to country to treat COVID-19 patients.
Remdesivir is a product of Gilead Sciences, Inc. and the company also recently signed an agreement with Jubilant Life Sciences Limited. Under this agreement, Jubilant Generics Limited, a subsidiary of Jubilant Life Sciences Limited, can register, manufacture and sell Gilead’s investigational drug remdesivir. “We plan to produce the drug’s Active Pharmaceutical Ingredient (API) in-house helping its cost effectiveness and consistent availability,” Shyam S Bhartia, Chairman and Hari S Bhartia, Co-Chairman and Managing Director, Jubilant Life Sciences Limited, said in a statement. The company also said that it will be monitoring the clinical trials and regulatory approvals to quickly launch the drug after securing regulatory approvals.
While remdesivir has secured EUA, it is not equivalent to USFDA approval which requires a company to submit formal new drug application submission, post which an approval process is undertaken. Remdesivir is only a temporary measure approved for the treatment of COVID-19 only. Besides remdesivir, other drugs such as Favipiravir and anti-malarial drug Hydroxychloroquine are also being used in the treatment of coronavirus. Mumbai-based Glenmark Pharmaceuticals had also recently announced that it has secured approval from the Drug Controller General of India to conduct clinical trials of Favipiravir on COVID-19 patients.