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March 25, 2020
Bayer, Novartis, Mylan, Teva, report that they are working on supply.
March 02, 2020
Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.
December 06, 2019
Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.
November 02, 2019
Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.
October 17, 2019
Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.
October 02, 2019
Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.
October 01, 2019
Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company.
An understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.
September 16, 2019
EMA plans to issue new guidance, as US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.
August 02, 2019
The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.