To sell the pharmaceutical product in any country, your manufacturing plant will inspect by the respective country’s regulators’ authority. Then these regulators’ authorities provide an Approval certification to the manufacturing plant for a certain time period. Then formulation plant authorizes to manufacture the pharmaceutical product for the respective country.
Market name Regulatory authority Name
WHO World Health Organization GMP certification
India CDSCO GMP certification
United States (United States Food & Drug Administration)
United Kingdom (The Medicines and Healthcare products Regulatory Agency)
Russia Russian GMP
Brazil ANVISA (The National Health Surveillance Agency)
Australia TGA (Therapeutic Goods Administration)
European Union EU GMP (European Medicines Agency)
PIC/S PIC/S (The Pharmaceutical Inspection Co-operation Scheme)
Taiwan TFDA ( Taiwan Food and Drug Administration)
All regulatory Authorities will audit/Re-inspect every pharmaceutical formulation plant within a specific time interval (Once in 2 or 3 years) and provide non-compliances report & Approval. Also, every county has its pharmacopeia like IP, USP, BP Etc.