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April 2020
Dr. Reddy’s was one of the very first API manufacturers to instigate a complete review to ensure that nitrosamine impurities are avoided by design and analytical methods are in place which meet the future stringent limits which have been set by regulatory agencies.
On winning the API Supplier of the Year award at the Generics Bulletin’s Annual Global Generics & Biosimilars Awards 2019, Dr. Reddy’s was also commended on the proactive and methodical approach followed to address the nitrosamine impurities situation with Sartan APIs (such as Valsartan).
Read the complete article here:
You can also read our whitepaper on “Meeting the New Regulatory Requirements in Sartan API Production” by clicking here:
https://api.drreddys.com/white-paper/meeting-new-regulatory-requirements-sartan-api-production-0
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