TDS Desk:
Bangladeshi pharmaceutical company Renata can now export Cabergoline 0.5mg tablets to Europe.
Cabergoline, a dopamine agonist, is primarily used in the treatment of conditions such as hyperprolactinemia and Parkinson’s disease.
Renata PLC announced the successful approval of the tablets from the EU Decentralized Procedure (DCP) Monday (2 September) in a filing with the Dhaka Stock Exchange (DSE).
This approval comes with access to several European markets such as Ireland, France, Portugal, Italy, Denmark, Sweden, Netherlands, Norway, and Spain.
“This significant 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,” Renata said in its DSE filing.
It said the tablet, Cabergoline 0.5mg, will be manufactured at Renata’s state-of-the-art UK MHRA-approved potent facility, which adheres to stringent quality control measures and is equipped to meet the demands of the European market.
“This product will be distributed across Europe through multitudes of strategic partnerships, ensuring widespread patient access,” it said.
Furthermore, Renata said the medicine is available in the local market of Bangladesh under the name Cabolin.
In September last year, 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.