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Renata gets EU regulator approval for drug export

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Renata PLC, a listed drug maker in Bangladesh, has got approval from the European authority to market a tablet, Cabergoline 0.5 mg, used for the treatment of Hyperprolactinemia and Parkinson’s.
The approval will enable Renata to access several European markets such as Ireland, France, Portugal, Italy, Denmark, Sweden, Netherlands, Norway, and Spain and reach out to patients there, the drug maker said in a press release.
“This milestone reflects Renata’s commitment to expanding its product offerings in the European market with strong competency in developing and delivering low dosage, high potency complex products,” said Renata.
The company said Cabergoline 0.5 mg will be manufactured at its facility approved by the UK Medicines and Healthcare Products Regulatory Agency.
The plant, located at Rajendrapur, Gazipur, adheres to quality control measures that are equipped to meet European market demand, it added.

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