Regulatory and Standard Setting Organizations

An ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.

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

The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.

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

A total of 13 drugs were granted recommendation for market authorization at EMA’s CHMP June 2025 meeting.

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.