CPP is the document that confirms a pharmaceutical product has met the quality, safety, and efficacy standards of the US FDA. CPP can be used to market pharmaceutical products in another country. Also, it helps to streamline the process by providing a summary of the technical data already reviewed and approved.
Pharmaceutical manufacturers and private label distributors who want to export their products to other countries are required to have CPP for their drugs.
Regulatory authorities in the importing countries may ask for CPP to ensure that the drug they are importing is following the regulations of the exporting country.
CPP contains the information about the product, such as its name, dosage form, and active ingredients, drug listing number, manufacturer information and the label image.
It contains a statement confirming the product’s marketing authorization status in the issuing country.
Benefits of getting CPP are getting faster registration process in other countries. Reduced costs for manufacturers by avoiding full re-evaluation of the product and improved access to essential medicines for patients in importing countries.
Liberty Management Group, a leading FDA consulting firm provides assistance with FDA drug establishment registration, drug listing and certificate to Pharmaceutical Product.
Sudha S
Regulatory Consultant
Email : office@libertymanagement.us
www.fdahelphttp://www.fdahelp.us.us