Serialization initiative makes progress towards uniform track and trace model
The initiative brought together competing vendors working “side by side,” focusing on a common goal of creating industry-wide standards.
Archives for August 15, 2016
update
US FDA changes policy on switching hard gel capsule suppliers
Drug manufacturers that change hard gelatin capsule suppliers do not need to seek approval beforehand under a policy introduced by the US FDA this week.
Antibiotic resistance most imminent threat to humanity, says bacteriophage maker
Phages, peptides and live biotherapeutics could help combat antibiotic-resistant bacteria but don’t expect heavy R&D investment until people start dying from post-operative infection, says EpiBiome.
Alcami plans to increase API production capacity
Alcami has announced plans to expand its facilities in Germantown, Wisconsin, in order to increase its Active Pharmaceutical Ingredient (API) production.
Crown Bio adds services at newly expanded oncology center
Crown Bioscience has expanded its oncology services with new models, cell lines, and assays at its San Diego-based Center of Excellence for Oncology.
Ash Stevens acquired by India-based CDMO
Ash Stevens has been acquired by Piramal Pharma Solutions, an India-based CDMO, in what the CEO said is an "incredibly powerful combination."
Statin APIs from Gedeon Richter-linked firm should be prohibited say GMP inspectors
German regulators want statin APIs made by Artemis Biotech to be banned after finding deviations good manufacturing practice (GMP) at the firm’s facility in Hyderabad, India.