Renata approved to enter German market with anti-Parkinson's drug
This is the first of many approvals Renata expects to attain from the German Federal Institute for Drugs and Medical Devices (BfArM) for its products
Renata Limited's European subsidiary Renata Pharmaceuticals (Ireland) Limited has secured the EU and German regulatory authorities' approval to launch its anti-Parkinson's therapy, Cabergoletten 1mg and Cabergoletten 2mg, according to company officials.
This is the first of many approvals Renata expects to attain from the German Federal Institute for Drugs and Medical Devices (BfArM) for its products, said Syed Omar Kabir, Renata's general manager for pharmaceutical business.
"We have been present in the stringently regulated pharmaceuticals markets, including Australia, the USA, Canada, the UK and the European Union, with over 25 products approved there," he added.
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The company has 64 bioequivalent products – which is the fundamental criterion for entering regulated markets, and it currently operates in 40 countries.
The strict German market approval is another milestone for the publicly traded Bangladeshi company that turned into Renata Limited from Pfizer Bangladesh in 1993.
According to Kabir, the top-tier company in the local market, which places great emphasis on research and development (R&D), regularly conducts rigorous clinical trials for their products, and has 14 state-of-the-art manufacturing facilities, started exporting drugs to the EU and the UK in 2015 and opened its UK subsidiary to boost exports in the European market.
Following Brexit, Renata opened another subsidiary in Ireland to operate effectively within the EU market.
Right now, the company has seven drugs approved in the US market and has several new applications planned for 2024.
"Having ensured world-class manufacturing and extensive R&D capabilities across our seven R&D centres, we are now filing our new drug applications in the most stringently regulated markets almost every month, and our 100% success rate thus far is very encouraging," said Kabir.
"We at Renata are establishing ourselves on the global pharmaceutical map through our excellence in R&D and manufacturing," he added.
Europe is an attractive market to pursue as it values niche and complex products – a key strength of Renata's R&D and manufacturing teams, and the company is set to enter the France, Norway, Denmark, Sweden, Spain and Portugal markets in the coming months.
The momentum was reflected in its export value growth, which was more than 67.5% higher in July this year compared to the same month in 2022.
"Our plan is to maintain high double-digit growth in exports as we continue to increase the number of products in highly regulated markets and continue to expand our capabilities in R&D and drug development," Kabir said.
