Date: 01-Jul-2020

Gujarat FDCA Issues Test License To Hetero To Manufacture Lyophilized Injection Of Remdesivir To Treat Critically Ill COVID-19 Patients

The Gujarat Food and Drug Control Administration (FDCA) has issued test license to Hyderabad-based Hetero Labs to facilitate manufacturing of lyophilized injection of remdesivir drug meant for treatment of critically ill COVID-19 patients in Gujarat.

Lyophilized injection is considered as an alternative to oral solid dosage forms for better patient compliance especially in hospitalized patients. Lyophilized injections are also prescribed to attain maximum bioavailability and stability in patients suffering from a number of diseases. As per the conditions of test license as prescribed in Form 29, Hetero Labs Ltd is hereby licensed to manufacture remdesivir for injection in strength of 100mg/vial, remdesivir for injection 100 mg/20ml, remdesivir for injection 100mg/vial with 20ml sterile water for injection (Combipack) for purposes of examination, test and analysis at Gufic Life Sciences, Navsari, Gujarat. The license is subject to the condition prescribed in part VIII of the Drug Rules, 1945. The license shall be in force for three years from June 24, 2020 to June 23, 2023.

“Test license is a prerequisite for the company to further manufacture lyophilized injection of remdesivir drug based on a loan licensing agreement. Gujarat has large facilities for producing lyophilized injections and therefore we have issued test license to Hetero as the company is well equipped to facilitate manufacturing of remedesivir in lyophilized injection form for better clinical outcomes,” informs Gujarat FDCA Commissioner Dr H G Koshia.

Form 29 is a licence to manufacture drugs for the purpose of examination testing and analysis. The applicant cannot perform any manufacturing activity other than for examination, testing and analysis purpose in the proposed manufacturing site. Hetero has already received the manufacturing and marketing approval for the investigational antiviral medicine remdesivir from the Drug Controller General of India (DCGI) for the treatment of COVID-19 patients. Hetero’s generic version of remdesivir will be marketed under the brand name Covifor in India.

The drug remdesivir has been granted approval 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.