STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced API Impurity Identification services for clients in the medical device, ...

CD Formulation, a leading provider of analytical and formulation services, has recently announced the launch of its new Genotoxic Impurity (GI) Testing services. This innovative offering aims to ...

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients. Effective and safe APIs provide the necessary ...

The pioneer method combines the nitrosation assay procedure (NAP) with 15N-enriched nitrosating reagents and 15N NMR ...

Our FDA Compliance & Enforcement Team highlights key takeaways from the Food and Drug Administration’s notice identifying scientific and regulatory considerations for nitrosamine drug ...

The global recall of valsartan has now extended to Pfizer and to Japan, via Mylan and India. According to a translated copy of its announcement, Pfizer’s Tokyo-based Japanese subsidiary said it is ...

Mylan N.V. announced that its US based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of nizatidine capsules, USP (including the 150mg ...

The Food and Drug Administration (FDA) has provided an update on its investigation into Valsartan HCTZ, a popular medication used to treat high blood pressure. The agency says tests on some of the ...

Discovery of the allosteric inhibitor from actinomyces metabolites to target EGFR CSTMLR mutant protein: molecular modeling and free energy approach Seven commercial samples from different origins ...

Sustainability of small-molecule API manufacturing ensures continued success. Improving the sustainability of small-molecule API manufacturing is essential to ensuring the continued success of the ...