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March 31, 2020 EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic…
Coronavirus disease has taken world by storm. Currently, not even a single country is immune to this deadly disease. Till now, this deadly disease has taken lives of more than 35000 people and more than 750 thousand people are infected…
February 28, 2020 The U.S. Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a…
Every pharmaceutical manufacturer sometimes goes berserk about ever changing regulations and multiple interpretations of the same guideline by various GMP experts. One of the grey areas is storage of reference and retention samples. This becomes an area of big concern…
Why Media Fill? During manufacturing of sterile formulations viz. Small Volume Parenteral (SVP), Large Volume Parenteral (LVP), Vaccines and other similar formulations, it is important to ensure that the manufacturing process itself is aseptic. Additionally, it provides another level of…