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).

In the article, Rajesh Sadanandan, Region Head – North America & Europe API, Dr Reddy’s, explained that pharma companies, API suppliers and ingredients manufacturer with a strong patient-focused culture are typically best positioned to anticipate and respond to these challenges, which ultimately will increase both access to high quality medications as well as patient health.”

Read the complete article here:

https://www.globalpharmainsights.com/manufacturing-outsourcing/nitrosamine-contamination-pharmas-re-evaluation-its-supply-chain

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