Gujarat FDCA: Test license issued to Hetero for manufacturing lyophilized injection of remdesivir

Test license has been issued by the Gujarat Food and Drug Control Administration (FDCA) to Hyderabad-based Hetero Labs for facilitating manufacturing of lyophilized injection of remdesivir, the drug meant for treatment of critically ill COVID-19 patients in Gujarat.
Considered an alternate to oral solid dosage, Lyophilized injection is basically 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.

Hetero Labs Ltd is licensed as per the conditions of test license as prescribed in Form 29 for manufacturing 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.
Gujarat FDCA Commissioner Dr H G Koshia said that the “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.”

For manufacturing the drugs Form 29 is a licence for the purpose of examination testing and analysis. No applicant can perform any manufacturing activity other than for examination, testing and analysis purpose in the proposed manufacturing site.
Earlier, 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. The generic version will be known as Covifor in India.

Approval for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children has already been given to the drug remdesivir to the patients hospitalized with severe symptoms of the disease.

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