Certificate To Pharmaceutical Product (CPP)

A Certificate of Pharmaceutical Product (CPP) is an internationally recognized document that confirms a pharmaceutical product's marketing status and regulatory compliance. FDA is issuing it to facilitate exporting FDA-regulated products from the United States.

The CPP provides information about the product, such as the product name, dosage form, strength, manufacturer, and regulatory status in the country of origin. It serves as evidence that the product is authorized for sale in the country of origin and meets the regulatory requirements for quality, safety, and efficacy.

Foreign governments seek official assurance that products exported from the United States to their countries can be marketed in the United States or meet specific U.S. regulations, such as current good manufacturing practice (CGMP) regulations. A foreign government may also require export certification as part of registering or importing a product into that country.

The pharmaceutical manufacturer must apply to the FDA to obtain a CPP, where the product is authorized for sale. The application must include information about the product, its regulatory status, and the intended recipient country. FDA will review the application and issue the CPP if the product follows their regulations.

It is important to note that the requirements for obtaining a CPP may vary between countries and regions. Some countries may require additional documentation or information, while others may not recognize the CPP.

Requirements to get the Certificate to Pharmaceutical Product (CPP)

  • The manufacturing facility must have a valid drug establishment registration.
  • All drugs must be listed with the FDA.
  • The drugs should meet all the drug labeling requirements as of 21 CFR 201.
  • The drugs should be manufactured in accordance with 21 CFR 211, also known as Good Manufacturing Practice.

Liberty Management Group Ltd., a leading FDA consulting firm, assists with FDA drug establishment registration, drug listing, and certificate to Pharmaceutical Product.

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