Hyderabad: Hyderabad-based Hetero has been awarded 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.
Hetero’s generic version of Remdesivir will be sold under the brand name ‘Covifor’ in India.
Dr. B Partha Saradhi Reddy, chairman, Hetero Group of Companies, said, “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. 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 Prime Minister.”
The drug ‘Remdesivir’ has been given 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 needs 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 to expand access to Covid-19 treatment in low and middle-income countries.
Remdesivir is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into a vein. As of 2020, remdesivir is being tested as a specific treatment for COVID-19, and has been authorized for emergency use in the US, India, Singapore, and approved for use in Japan for people with severe symptoms. It also received approval in the UK in May 2020, however, it was going to be rationed due to limited supply. It may shorten the time it takes to recover from the infection.
Side effects may include liver inflammation and an infusion-related reaction with nausea, low blood pressure, and sweating. It is a prodrug that is converted in the body into GS-441524, a ribonucleotide analog.
Earlier studies found antiviral activity against several RNA viruses including SARS coronavirus and MERS coronavirus, but it is not approved for any indication. Remdesivir was originally developed to treat hepatitis C and was then tested against Ebola virus disease and Marburg virus disease, but was ineffective for all of these viral infections.
Hetero Group is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. Backed by over 25 years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Generics, Biosimilars, Custom Pharmaceutical Services and Branded Generics. The company is globally recognized for its strengths in Research and Development, manufacturing and commercialization of a wide range of products.
Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide, audited and approved by stringent regulatory authorities like the US FDA, EU, TGA-Australia, MCC-South Africa, and others. Our portfolio includes 300 plus products encompassing major therapeutic categories such as HIV/AIDS, Oncology, Cardiovascular, Neurology, Hepatitis, Nephrology, Urology, Diabetes, Ophthalmology, Hepatology and Immunology, etc.
Hetero has a strong global presence in over 126 countries and focusses on making affordable medicines accessible to patients worldwide.