Jul 09, 2018

Farmak JSC obtained GMP Certificate of the European Regulator HALMED (Croatia)

EMA’s European database now contains a GMP Certificate issued by the Croatian regulator following the inspection held at Farmak JSC during 18-22 December 2017.

The Certificate is valid within 3 years and covers 13 manufacturing sites for sterile and non-sterile medicinal products.

“Quality is a core Farmak’s principle. Passing of the international inspection once more proves high quality of the medicinal products the Company manufactures and efficient operation of its pharmaceutical quality system. Positive results of the inspection enable extending of Farmak’s presence in European and other foreign markets. As of July 2018, the European GMP Certificate covers 14 manufacturing sites. Farmak passes over 15 international inspections annually. This allows us exporting our products to more than 20 countries. The share of export in the company’s sales volumes is about 25.1%. By 2020, we are planning to increase our share of export up to 40%”, says Volodymyr Kostiuk, Acting Executive Director, Farmak JSC.

It is worth mentioning that in December the said regulator inspected Farmak JSC for the third time. During the inspection 8 manufacturing sites were re-inspected and 5 were inspected for the first time.

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