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From our Knowledge Center
GMP audits reports during COVID-19 times
Completing a Good Manufacturing Practices (GMP) audit report prior to 2020 was simple. Companies had many ways to get theirs done, and a...
Teva api Adopts New Nitrosamine Regulations
In September, 2019, the EMA (European Medicines Agency) and EDQM (European Directorate of Quality of Medicines) published a document...
Navigating China’s API Regulations
Regulations pertaining to APIs in China have changed. Here at Teva api, our Regulatory Affairs team in Beijing is on the ground to help...
Our operational presence in Europe and how COVID-19 has changed the playing field
Here at Teva api, we’ve had a significant operational presence in Europe for many years. Over the last few months, as COVID-19 spread...
Regulations in Brazil are Changing
On April 1st, 2020, Brazil’s ANVISA published new landmark regulations referring to active pharmaceutical ingredients (APIs). This new...
Creatively using co-crystals to produce alternative generic products
Co-crystals and APIs Crystal formulations can be fundamental to the performance of medicines that have inherent barriers to drug delivery...
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