| |DECEMBER 20259GRANULES CONSUMER HEALTH CLEARS USFDA INSPECTION WITH ZERO OBSERVATIONSANOFI SECURES VICEBIO TO ADVANCE NEXT-GEN RESPIRATORY VACCINESGranules India reported that its subsidiary in the U.S., with step-down operations, Granules Consumer Health, LLC, has passed a Good Manufacturing Practice (GMP) inspection conducted by the U.S. Food and Drug Administration (FDA) with zero observations. This is the second FDA audit of the facility, the first being the March 2023 inspection, when a No Action Indicated (NAI) classification was assigned to the facility."Granules Consumer Health plays a critical role in our global operations as a packaging and distribution site. We process controlled substances and over-the-counter (OTC) products across three advanced packaging lines. Achieving zero observations in this inspection reflects our unwavering focus on quality, safety, and regulatory excellence," said Dr Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India.Granules Consumer Health is a front-end operation of Granules India in the U.S., where OTC products can be utilized, taking advantage of the manufacturing efficiencies, regulatory compliance, and supply chain of the company. The effective FDA inspection affirms the company to provide quality pharmaceutical products to the American market.Industry pundits consider this accomplishment one of the milestones of the growth strategy of Granules India in the regulated market. Having strong compliance programs and a sound emphasis on quality, Granules will be in a good position to enhance its role in the very competitive pharmaceutical and OTC industry in the United States.The zero-observation FDA clearance also indicates that Indian pharmaceutical firms are increasingly able to play up to international standards to provide healthcare products that are safe, effective, and reliable to the rest of the world. The performance of Granules Consumer Health highlights the changing position of India as a reliable ally in the pharmaceutical market in the world. POSanofi has completed the acquisition of Vicebio Ltd, and this will make it stronger in the vaccine portfolio and prove its role as an innovative biopharma leader.The acquisition combines an exciting early-stage combination vaccine against respiratory syncytial virus (RSV) and human metapneumovirus (HMPV) two significant respiratory infections which impact millions annually.This addition will help Sanofi to pay more attention to respiratory health and provide doctors and patients with more opportunities.The program obtained is based on the Molecular Clamp technology developed by Vicebio that stabilizes the viral proteins in their pre-fusion state. This increases immunogenicity and allows an improved design of vaccines. In the case of Sanofi, a combination of this technology, combined with its own R&D assets, offers new instruments to shorten the time to develop next-generation vaccines.The introduction of a non-mRNA RSV vaccine candidate also increases the respiratory product line and expands the market of Sanofi. It is also in line with the long-term objective of the company to offer various forms of vaccines, which will provide healthcare providers with more options as this global demand to stay safe against RSV and HMPV increases.Sanofi characterizes itself as a biopharma company that is R&D and AI driven and focuses on bettering lives via advanced science. The company uses its in-depth understanding of the immune system to innovate medicines and vaccines currently defending millions of people all over the world. Sanofi is committed to delivering new solutions that have the potential to reach more people over the next years with a scale-designated pipeline which can make a difference in patient lives. PO
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