planetregulatory

WITH MARKET VALUE EXPECTED TO HIT $50 BILLION BY 2025, THE REGION IS ONE OF THE MOST LUCRATIVE MARKETS FOR GLOBAL PLAYERS Be it the expanding population, unmet medical needs, growing middle class population, longer life expectancy, lower mortality rates or rising income levels, the Middle East and North Africa (MENA) region has everything that [...]

On July 17, 2018 and July 18, 2018, respectively, the EMA and the FDA reported a major issue regarding the detection of a genotoxic impurity, NDMA (N-nitrosodimethylamine), and subsequently NDEA (N-nitrosodiethylamine), in current lots of valsartan,1 an API used to manufacture generic angiotensin receptor blockers (ARBs). The API at issue was supplied by two Chinese companies, [...]