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The company's dossier compiled under EU guidelines have fetched this second approval in continuation to the journey of their research-driven API-integrated EU GMP approved oncology formulation ...
Any manufacturer (or importer) of medicine intended for the EU market must comply with GMP standards, regardless of where production occurs. These are the rules if you want to play the game in Europe.
The U.S. Food and Drug Administration’s (FDA’s) evolving guidance on Computer Software Assurance and AI/ML-Based Software ...
Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course" training has been added to ...
With the GMP certification in an EU member state, Portocanna is well positioned to supply medical cannabis fr. SAN FRANCISCO, May 16, 2024 (GLOBE NEWSWIRE) -- Ziel, ...
Venus Remedies has secured the renewal of its EU-GMP certification from Infarmed, Portugal, for its Cephalosporin, Carbapenem, and Oncology formulations manufacturing facility. This renewal ...
Following the most recent revision to the EU GMP Annex1 in 2020, Eric Clement Arakel (Global Product Manager) and Myriam Gueye (Segment Marketing Manager, Applied Industries) at Sartorius will ...
Marijuana entrepreneurs in America have high hopes for growth in the EU, which has friendlier regulations and lower taxes. Here’s why it could bloom into a $50 billion market that eclipses the U.S.
The revised EU Good Manufacturing Practice (GMP) Annex 1 has evolved to improve public health. Specifically, the change has introduced a more unified version of guidelines for the manufacturing of ...
Between 1999 and 2000, Imexpharm continued its technological advancements by constructing a GMP-ASEAN Betalactam oral medication factory and initiating franchise production in partnership with the ...
SAN FRANCISCO, May 16, 2024, the industry leader providing next-generation customized, microbial control solutions for the agriculture and cannabis industries, today announced that its partner ...