Optimus becomes the First Company to Conclude Study of Molnupiravir Phase 3 Clinical Trial with Promising Results
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.
About Optimus Pharma
Optimus was established in the year 2004 as custom synthesis laboratory by a team of techno-commercial experts. It is one of the fastest growing Manufacturer in Active Pharmaceutical Ingredients (APIs) and Finished dosages. Over the last decade we have been certified and audited by reputed Global Regulatory Agencies like USFDA, WHO, COFEPRIS, EMA, KFDA and AFM from PMDA Japan. Optimus Pharma is a vertically integrated pharmaceutical company engaged in manufacturing of Solid Oral and semisolid formulations. We have successfully integrated our API and Formulation R&D teams with the IP and Regulatory Affairs team in order to ensure a dynamic product portfolio. We help our customers serve global markets with technology based, innovative, cost effective & consumer friendly products of the highest quality. www.optimuspharma.com.