Renata gets EU approval to export drug for Parkinson's disease

Renata Ltd. has recently secured approval from the EU Decentralised Procedure (DCP) to export Cabergoline 0.5mg tablets to Europe.

Cabergoline, a dopamine agonist, is primarily used in treating conditions such as hyperprolactinemia and Parkinson's disease.

The drug maker announced this milestone in a stock exchange filing on Monday, highlighting the successful approval of its tablets under the EU DCP.

The EU DCP, a regulatory procedure within the European Union (EU), facilitates the authorisation of certain human and veterinary medicinal products.

This approval marks Renata's expansion into yet another stringent regulated market, reflecting the quality and global standards of its products.

Following this approval, Renata can 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," said Company Secretary Md. Jubayer Alam.

The Cabergoline 0.5mg tablets will be produced at Renata's state-of-the-art UK-MHRA-approved potent drug facility, which adheres to stringent quality control standards and is fully equipped to meet the requirements of the European market.

This product will be distributed across Europe through multitudes of strategic partnerships, ensuring widespread patient access, he said.

Furthermore, Renata said, this medicine is available in the local market of Bangladesh under the brand name Cabolin.

Following the announcement, Renata's stock price rose by 0.16%, closing at Tk 770.20 on Monday, even as the market ended lower.

Renata, one of the fastest growing drug makers in Bangladesh, has been heavily focused on research and development (R&D) of complex generics for several years.

The company manufactures and markets medicines, nutritional products, and vaccines for humans along with veterinary medications.

Renata is also the contract manufacturer for UNICEF and SMC for general products, such as birth control pills, oral saline, and micronutrient powders.

In April this year, the drug manufacturer started exporting medicines to the US market directly from its US-FDA-approved facility in Rajendrapur, becoming the sixth pharmaceutical manufacturers from Bangladesh to directly ship products to the world's largest market.

In May, Renata also shipped an initial consignment of Levonorgestrel 1.5mg tablets, which is the first registered product of Renata in Australia.

In June, Renata exported its first shipment of Terbinafine tablets to the UK market. With the new types of drug shipment, the export basket of Renata increased to 17 products for the UK market.

In September last year, Renata's European subsidiary Renata Pharmaceuticals (Ireland) has secured the EU and German regulatory authorities' approval to launch its anti-Parkinson's therapy, Cabergoletten 1mg and Cabergoletten 2mg.