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PLIVA Kraków has obtained FDA approval for products intended for the US market

PLIVA Kraków is the first company in Poland to have obtained the approval of the US Food and Drug Administration (FDA) for the manufacture of drugs intended for the US market.

FDA’s approval is a confirmation that PLIVA Kraków satisfies the very strict US requirements concerning not only the manufacturing process and the ready-made drugs, but also quality control and other processes involved in the operation of the facility as a whole. In order to obtain the approval, PLIVA had to successfully undergo a comprehensive inspection by FDA. The audit was carried out in Krakow in May 2005 and brought very good results.

“FDA’s audit in PLIVA Kraków was a real challenge to all employees working at our facilities. FDA inspectors are renowned for their conscientiousness and very high standards. We are therefore all the more happy that the result of the audit was positive. It is worth noting that the certificate obtained by PLIVA is the first FDA approval awarded to a pharmaceutical company in Poland for the entire drug manufacturing process”, said Justyna Lubaska, Quality Assurance Director in PLIVA Kraków.

„We are proud to have obtained FDA approval for the manufacture of drugs intended for the US market. This is yet another – after the MHRA certificate – proof of the supreme quality of our manufacturing practices and the drugs manufactured in PLIVA’s Krakow-based facilities. With the FDA approval, PLIVA Kraków will strengthen its strategic position in the PLIVA Group in terms of its manufacturing and logistic role”, added Hrvoje Perković, PLIVA Kraków’s Managing Director.

PLIVA is the second largest investor in the Polish pharmaceutical industry in terms of the volume of outlays, and one of the biggest manufacturers of generic drugs in Poland. The company manufactures drugs of supreme quality, which – apart from the FDA approval – has been confirmed by the Medicines and Healthcare Products Regulatory Agency (MHRA) certificate which authorizes production for the EU market. PLIVA was the first pharmaceutical manufacturer in Poland to obtain the MHRA certificate in 2003. The company offers about 110 drugs coming in 300 different forms and doses, including such well-known preparations as Flegamina, Hepatil, Calcium, Venotrex, Vitamin C Monovitan, Aviomarin and Infex.

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