A closer look on how Dr. Reddy's met the stringent regulatory requirement of genotoxic impurities in Ranolazine
Genotoxic impurities (GTIs) have recently challenged the pharmaceutical industry by virtue of their presence at a level of parts per million (ppm) in drug products, especially in high dosage molecules like Ranolazine, which has a prescribed maximum daily dosage (MDD) of 2000 mg.
In this whitepaper, we talk about steps taken by Dr. Reddy's during the product development phase to address this challenge by designing the process in such a way that all these PGIs / GTI’s are within the control in the manufacturing approach followed by Dr. Reddy’s for Ranolazine.
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