In this blog, we’ll focus on answering your questions about the SFCR License and Preventive Control Plans, including why they are important and how they... Read more
There are several monograph categories for OTC Drugs in Canada, such as Labeling Standard, TPD Category IV, and NSAIDs. Meeting their requirements is difficult.
To market OTC drugs in USA, you need to go through two Regulatory Pathways, OTC Drug Monograph Application Process and the OTC New Drug Application (NDA) process.
Any firm (domestic or foreign) manufacturing, distributing, or importing OTD drugs require to show evidence that they are following GMP.
To manufacture, sell, or import non-prescription drugs, businesses must obtain an establishment license.