104 Indian pharmaceutical manufacturers confirmed their GMP compliance in Ukraine

| By | GMP certificate, GMP Standards, India, Ukraine
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As of early June a total of 104 pharmaceutical industrial sites from India confirmed their compliance with Good Manufacturing Practice (GMP).

The Indian Pharmaceutical Manufacturers’ Association in Ukraine (IPMA) told Interfax-Ukraine, referring to the State Service for Medicines and Drugs Control, at present there are 72 conclusions effective in Ukraine and issued by the authority for applicants from India on the basis of certificates issued by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).

In addition, some 32 certificates were issued by the State Service for Medicines and Drugs Control to the applicants from India after inspections at the production sites in India.

The authority’s experts are handling 18 more applications to receive the certificates. Work on nine applications to confirm compliance with GMP from Indian productions sites in in progress.

“The importance of Indian pharmaceutical production is admitted by the World Health Organization (WHO), as Indian generics allow considerably cut the cost of treatment,” WHO representative in India Henk Bekedam said.

The IPMA (the Indian Pharmaceutical Manufacturers’ Association) brings together Indian pharmaceutical manufacturing companies that meet high international standards, including US FDA (the United States), UK MHRA (Britain), MCC (South Africa), TGA (Australia), WHO GMP (WHO), GMP (Ukraine), which have representative offices in Ukraine.

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme has 44 members, including over 30 regulatory agencies of various countries.

SOURCE: interfax-ukraine
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