MUMBAI, India, Nov. 14 -- Intellectual Property India has published a patent application (202421036875 A) filed by Alembic Pharmaceuticals Limited, Vadodara, Gujarat, on May 8, 2024, for 'an improved process for reducing content of nitrosamine impurity in drug substance.'
Inventor(s) include Tomer, Sanjiv; Kanzariya, Kamlesh; Ninave, Nikhil; Panchal, Jaykumar; and Panchal, Chirag.
The application for the patent was published on Nov. 14, under issue no. 46/2025.
According to the abstract released by the Intellectual Property India: "The present invention relates to process for reducing content of nitrosamine impurity represented by formula (II) in drug substance of formula (I) or its intermediate of formula (I) or its salt thereof, which comprises; subjecting drug substance of formula (I) or its intermediate of formula (I) or its salt thereof containing nitrosamine impurity (II) to hydrogenation reaction in presence of hydrogen source, metal catalyst and suitable solvent(s)."
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