India, Hyderabad; 21 March, 2022: Hetero, a globally renowned vertically integrated pharmaceutical organization announced today that its biologics arm ‘Hetero Biopharma’ has received approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture for sale, Sputnik Light, with restricted emergency use in India. Hetero is the first biopharmaceutical company in India to receive manufacturing & marketing (M&M) approval for the product manufactured locally for the prevention of COVID-19 in adults aged over 18 years, administered in single dose of 0.5ml. All other currently approved vaccines in India require two doses of administration.
Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of Sputnik V – the world’s first registered vaccine against coronavirus disease, COVID19. In February 2022, the Drugs Controller General of India (DCGI) granted emergency use permission to Single-dose Sputnik Light COVID-19 vaccine in India.
“Clinical data of Sputnik Light (Component I of Sputnik V) had shown significantly high titers of antibodies against COVID-19, both glycoprotein specific and virus-neutralizing antibodies along with CD4 & IFN-γ levels. Sputnik Light has also shown its neutralizing activity against Omicron variant of SARS CoV-2 virus. Earlier Sputnik V clinical trials globally had shown significant protection against COVID-19 including other subtypes,” said Dr. Shubhadeep Sinha, Senior VP & Head - Clinical Development & Medical Affairs (CDMA) at Hetero.
Hetero is a globally renowned vertically integrated pharmaceutical organization engaged in research and development, manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas. Backed by 27+ years of expertise in the pharmaceutical industry, Hetero’s strategic business areas spread across APIs, Global Generics, Biosimilars and Custom Pharmaceutical Services. The company is among the largest producers of Active Pharmaceutical Ingredients (APIs) in the world.
Hetero has 36 state-of-the-art manufacturing facilities strategically located worldwide, which has been approved by top pharma regulatory bodies of the world. Our portfolio includes 300+ products encompassing major therapeutic categories such as HIV/AIDS, Oncology, Cardiovascular, Neurology, Hepatitis, Nephrology etc. Hetero has a strong global presence in over 126 countries and focusses on making affordable medicines accessible to patients worldwide
Over the years, Hetero has established its strong leadership in ARVs and Antiviral therapies and caters to 40% of existing global demand for Anti-Retroviral (ARV) APIs and Finished Dosage Forms (FDFs) used in HIV/AIDS treatment. For more information on Hetero, please visit www.heteroworld.com.
For further details, please contact:
Head - Corporate Communications, Hetero
Mobile: 97036 20166