Gufic Lifesciences signs pact with Hetero Labs for Remdesivir lyophilised powder

Gufic Lifesciences Private Limited (GLPL) has entered into a loan license agreement with Hetero Labs Limited to manufacture and supply Remdesivir lyophilised powder for injection (100 mg/vial) on loan license basis to Hetero for its sale in various countries, including India.

Hetero was the first company in India to launch Remdesivir lyophilised powder for the injection indicated for emergency use in COVID-19 patients.

Remdesivir will be manufactured in the state-of-the-art Lyophilisation facility of GLPL situated at Navsari (Gujarat) and the said facility has been approved by EU-GMP, WHO-GMP, Ukraine GMP, South African authority, ANVISA (Brazil) and many other countries. GLPL has already received a manufacturing license for the said formulation from the drug authorities in India and also initiated supplies in countries like Kazakhstan, Philippines, UAE, and Indonesia, etc.

Remdesivir Lyophilised Powder for the injection is an investigational new drug developed by Gilead Sciences Inc, a Delaware Corporation based in California, USA. The USFDA granted emergency use authorisation of Remdesivir to treat hospitalised patients with severe COVID-19 in the United States. In addition, it is recommended for compassionate use in Europe and recently, received regulatory approval in Japan, Taiwan, and Singapore.

Gufic Biosciences and GLPL have expanded their infrastructure and it has now a capacity of over 50 million vials per annum, which makes Gufic Group, one of the world’s largest manufacturers of Lyophilised products.

Gufic Biosciences Ltd has made an application before honourable National Company Law Tribunal, Mumbai Bench (NCLT) for the amalgamation of Gufic Lifesciences Pvt Ltd into it. The shareholders’ meeting for their approval on the scheme will be held on September 15, 2020.

On Tuesday, in the early morning session, the stock of Gufic Biosciences surged 3.9 per cent to Rs 99.75 from its previous close of Rs 96 on BSE.