active pharmaceutical ingredient and excipient
-
After successful preclinical trials, the API enters clinical development, where it is tested in a series of progressively larger phases in human subjects. Each phase is designed to gather more data about the drug's safety and effectiveness. Depending on the results of these studies, the drug may eventually receive approval from regulatory bodies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), paving the way for commercial production.
api drug substance...
-
The API manufacturing sector is not without challenges. Increasing regulatory demands and the rising costs of raw materials have pressured manufacturers to maintain competitiveness while ensuring compliance. Additionally, the global nature of supply chains can introduce vulnerabilities. Events such as natural disasters, geopolitical tensions, or pandemics can disrupt the supply of critical raw materials.
active pharma ingredients manufacturers...