Renata PLC has secured regulatory approval to market its Thyrox (Levothyroxine Sodium) tablets in six European Union countries, expanding the Bangladeshi drugmaker’s presence in regulated overseas markets.
The approval, granted under the European Union’s Decentralised Procedure (DCP), covers Ireland, Germany, Italy, Poland, Portugal and Malta, the company said in a disclosure to the Dhaka Stock Exchange (DSE) on Thursday.
Renata said the product will be manufactured at its European Union Good Manufacturing Practice (EU GMP)-approved potent product manufacturing facility.
The company said it aims to support safe and reliable access to Levothyroxine in the newly approved European markets.
Renata shares, with a face value of Tk10 each, edged up 0.09 per cent to close at Tk456.40 on the DSE on Thursday.
