International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin‑Containing Medicines

Recent joint publication from FDA, EMA, LGL, CVUA, INPHA, SwissMedic, NIL, RIVM, Health Canada, HSA Singapure, TGA Australia

The research article provides an overview of the analysis of metformin active pharmaceutical ingredients (APIs) and drug products with 1090 samples (875 finished dosage forms (FDFs) and 215 API samples) tested beginning in November of 2019 through July of 2020. Samples were obtained internationally by a variety of approaches, including purchased, received from firms via information requests or selected by regional regulatory authorities (either at wholesalers or during GMP inspections)

Link: International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines | SpringerLink

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