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Biocon gets GMP certificate from European regulator for Bengaluru API plant
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Biocon gets GMP certificate from European regulator for Bengaluru API plant
Dec 23, 2022 4:46 AM

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Global biopharmaceutical company Biocon Ltd. has received a Good Manufacturing Practice (GMP) certificate from the European Directorate for the Quality of Medicines and Healthcare (EDQM) for its active pharmaceutical ingredient (API) manufacturing facility in Bengaluru.

The Bengaluru-based company on Thursday said that the certification was issued after a GMP inspection of the plant conducted between September 12 and September 14.

A Good Manufacturing Practice, according to the European drug regulator, European Medicines Agency (EMA), describes the minimum standard that a medicines manufacturer must meet in their production processes.

Also Read: Biocon begins clinical trial for Ulcerative Colitis treatment drug

The European Directorate for the Quality of Medicines and Healthcare (EDQM) is a directorate of the Council of Europe, which is a 47-member organisation. EDQM works with the European drug regulator EMA.

Biocon develops affordable biosimilars, generic formulations, and complex APIs. Its four global businesses include generics, biosimilars, research services, and novel biologics. Its active pharmaceutical ingredients are sold in approximately 120 countries, including the United States and Europe.

Its subsidiary Biocon Biologics Ltd (BBL) has commercialised eight biosimilars in key emerging markets and advanced markets like the United States, European Union, Australia, Canada, and Japan.

Shares of Biocon Ltd are trading 0.80 percent higher at Rs 271.80.

(Edited by : Rukmani Krishna)

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