Sanofi Healthcare India Pvt Ltd.

New Delhi: Dr Reddy's Laboratories on Monday said it has expanded its partnership with Sanofi Healthcare to introduce a novel drug for the prevention of lower respiratory tract disease in newborns. The company plans to introduce Beyfortus , which contains the monoclonal antibody, nirsevimab, in a prefilled injection used for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants. The medication is also administered in children up to 24 months of age, who remain vulnerable to severe RSV disease through their second RSV season. RSV is a highly contagious virus that can lead to serious respiratory illness in infants. Under the arrangement, Dr Reddy's will have exclusive rights from Sanofi to promote and distribute Beyfortus in India, the Hyderabad-based drugmaker said in a statement. The announcement follows Dr Reddy's successful exclusive distribution partnership with Sanofi for their portfolio of vaccines in India last year. Dr Reddy's is expected to launch Beyfortus in India in the second quarter of the current fiscal year. "Beyfortus enables the access of healthcare professionals and parents to an improved drug in the prevention of RSV," Dr Reddy's Laboratories CEO Branded Markets (India and Emerging Markets) MV Ramana said. Bringing Beyfortus to India is a pivotal step in the company's mission to protect every child from immunisation preventable diseases like RSV, Nitya Padmanabhan, Head of Sanofi Vaccines (India), said. Beyfortus has been approved for use in the European Union, the US, China, Japan, and many other countries around the world. In India, it received marketing authorisation approval in June last year from the Central Drugs Standard Control Organisation (CDSCO).

New Delhi: Sanofi Healthcare India on Monday said it has received marketing authorisation for a drug used for the treatment of Chronic graft versus host disease (cGVHD). The company has received approval for Rezurock ( Belumosudil tablets ), which represents a new treatment paradigm for cGVHD patients globally (12 years and above) after failure of two previous lines of treatment, including those with difficult-to-treat manifestations like fibrosis . Rezurock was approved by the US Food and Drug Administration ( USFDA ) and by the CDSCO in India in 2024. "This milestone reflects our dedication to addressing unmet medical needs in the transplant ecosystem and delivering breakthrough therapies for patients with this severe condition," Sanofi India MD Rodolfo Hrosz said in a statement. cGVHD is a complication that can occur following allogeneic stem cell transplantation, resulting in significant morbidity and mortality.

Sanofi has gained approval for IMOVAX-Polio, an alternative injectable vaccine. According to a report, this new vaccine will replace the Inactivated Polio Vaccine (IPV) ShanIP in India. IMOVAX-Polio is an alternative IPV vaccine that has been used in more than 100 countries for over 40 years, a Sanofi India spokesperson commented. The vaccine has the same composition/formulation as ShanIPV, the spokesperson added. “We wish to assure all stakeholders that there will be no shortage of IPV vaccines in India on our account, towards safeguarding the nation’s status of remaining polio-free. We remain fully committed to fulfilling our public health mission in India,” the spokesperson noted. To ensure that there is no interruption to the availability of IPV vaccines, the French firm has already obtained approvals for IMOVAX-Polio. “Sanofi has had to adapt its strategy and portfolio to these (emerging) trends. Accordingly, Sanofi Healthcare India Pvt Ltd (SHIPL) announced that by the end of 2023, it will discontinue ShanIPV, which was only filled and packaged at our factory in Hyderabad, India,” the spokesperson added. Launched in India in 2015, ShanIPV is a trivalent inactivated injectable vaccine. Under the government’s immunisation program, the vaccine was injected in two stages at six weeks and 14 weeks of age. Sanofi and Serum Institute of India are the leading suppliers of IPV vaccines in India. The French drugmaker is also planning to enhance its presence in the diabetes segment and grow its consumer healthcare business after spinning it off into a new entity while also looking at local production of its various best-in-class products in India. Sanofi has a pipeline of 12 different products lined up for launch in India.