Home » Health Canada Expects Minimal Manufacturer Costs From New GMP Requirements for APIs
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.
Drug Industry Daily
Drug Industry Daily
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