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The QMN Weekly Bulletin
Oct. 26, 2012 | Vol. 4 No. 43
Health Canada Expects Minimal Manufacturer Costs From New GMP Requirements for APIs
API makers with manufacturing facilities in Canada can expect nearly $1 million dollars in initial costs and $100,000 in annual compliance and administrative costs related to proposed manufacturing regulations. This represents a minimal burden on the industry, and the good manufacturing practice (GMP) regulations for APIs will net a nearly $35 million benefit over 10 years from savings, according to a cost/benefit analysis from Health Canada.
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