Resources, Guidelines, and Guidance Documents

Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.

The contract will support R&D of high-quality APIs for substance use disorders and mental health conditions, starting with synthesis and scale-up of psilocybin, which is derived from mushrooms.