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. Dr B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented: “In the light of increasing COVID-19 cases in India, the approval of ‘COVIFOR’ (Remdesivir) can prove to be a game-changer given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country.”

He has further added, ”We are prepared for ensuring enough stocks required to cater to the present needs. We will continue to work closely with the government and medical community to make a difference in the fight against COVID-19. This product is made indigenously in line with the ‘Make in India’ campaign as envisioned by our Hon’ble Prime Minister.”

The drug ‘Remdesivir’ has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalized with severe symptoms of the disease. COVIFOR (Remdesivir) will be available in 100 mg vial (Injectable) which has to be administered intravenously in a hospital setting under the supervision of a
healthcare practitioner. The product is launched under a licensing agreement with Gilead Sciences Inc. to expand access
to COVID-19 treatment in low and middle-income countries

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.

Story Input : www.dsij.in