COPP (Certificate of Pharmaceutical Product)
A WHO-format certificate confirming a product is manufactured and approved for sale in India, used by destination-country regulators to assess an import application.
Definition
The Certificate of Pharmaceutical Product, issued in WHO format by the State FDA or CDSCO, is the document a destination country's drug regulator actually reads when assessing an import registration. It confirms the product's approval status, manufacturing site and GMP compliance in the country of origin.
Why It Matters
For a merchant exporter, the COPP is obtained through the manufacturing partner — it is issued against their plant, not the exporter's office. Confirming a manufacturing partner holds a live COPP and WHO-GMP certificate is a standard step before any export quotation is issued.