PTSM: Pharmaceutical Technology Sourcing and Management
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
The European Medicines Agency (EMA) opened up for consultation product-specific guidance documents on bioequivalence studies for the active substances asenapine, prasugrel, sitagliptin, and zonisamide. The release of the guidance documents follows finalization of bioequivalence guidance on 16 active substances in 2014 and 2015.
The guidance documents, which can be found on EMA’s website, are available for comment until Nov. 1, 2015.
Source: EMA
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.