Hyderabad, November 03, 2021: Optimus Group has announced the successful completion of the much-awaited Molnupiravir Oral Capsule Phase 3 Clinical Trial. On May 18, 2021, Optimus received approval from the Drugs Controller General of India (DCGI) to conduct the trial as per the recommendations of the Subject Expert Committee (SEC) of the CDSCO, DGHS, Ministry of Health and Family Welfare.
The pharmaceutical company was the first to file for Phase 3 Clinical Trial of Molnupiravir with the Central Licensing Authority. The Clinical Trial partner of Optimus, JSS Research was tasked with the execution of the trial at the grass-root level. With 29 study sites across India roughly covering 96% of the nation’s demographic capital, the trial not only aims to prove the superiority of Molnupiravir over the standard treatment options but also prove the drug’s efficacy across India’s gene pool diversity.
In order to cater to the unmet medical needs of the nation for a front-end cure to SARS-CoV-2 infection, Optimus is well prepared to ensure manufacturing and distribution of Molnupiravir efficiently and effectively.
Speaking on the development, Dr. D. Srinivasa Reddy, Chairman and Managing Director Optimus Pharma said, “With an indigenously developed formulation, Optimus strives to establish its belief in the Make in India initiative of the Government of India. Our aim is to develop a cutting-edge and affordable treatment option for COVID-19 and neutralize the disease in minimum treatment duration. We are fully committed to supporting our business partners across various regions of the world who are counting on us for the supply of Molnupiravir. Optimus submitted the final clinical trial report with promising results.”
“These results are not only a new hope to neutralize COVID-19 but also reinforce our belief in the Central Licensing Authority of India to ensure a fair and legitimate trial and provide the necessary support for a self-reliant pharmaceutical industry. In the developing scenario, the CDSCO has emerged as a reliable central licensing authority in Asia promoting innovation and strict regulatory and quality compliance in the Pharmaceutical Industry,” he/she added.
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