Earlier, Roche lodged a complaint to the Drugs Controller General of India (DGCI), alleging Zydus might have procured the reference drug from an unauthorised supply chain to conduct the clinical trials and now for a formulation patent infringement. However, Roche does not currently hold a product patent for pertuzumab in India. It is a fact that Zydus’ Sigrima was approved by the Central Drugs Standard Control Organization (CDSCO) in April 2024 and permitted for sale in June 2024., Earlier, Roche lodged a complaint to the Drugs Controller General of India (DGCI), alleging Zydus might have procured the reference drug from an unauthorised supply chain to conduct the clinical trials and now for a formulation patent infringement. However, Roche does not currently hold a product patent for pertuzumab in India. It is a fact that Zydus’ Sigrima was approved by the Central Drugs Standard Control Organization (CDSCO) in April 2024 and permitted for sale in June 2024., , Read More
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