BM Desk : Renata has received approval from the European Union after European inspectors inspected one of its manufacturing plants, which will increase its export prospects.
The publicly traded pharmaceutical business reported in a filing to the stock exchange on Wednesday that, following a comprehensive review by European regulators, its Rajendrapur production facility had been granted European Union Good Manufacturing Practice (EU GMP) certification. Renata’s accomplishment places it among the few pharmaceutical companies in Bangladesh with EU GMP-certified facilities, such as Beximco Pharma, Incepta, and Square Pharmaceuticals.
Company representatives indicated that this certification has paved the way for Renata’s products to be exported to EU nations. Previously, Renata had been exporting its products to EU markets, albeit on a limited basis due to the lack of certification. “Now, we have the potential to obtain approvals for a significant number of our products from EU drug authorities,” stated Md. Jubayer Alam, the company secretary of Renata. The EU GMP certification verifies that the facility adheres to stringent European manufacturing standards for pharmaceuticals, encompassing aspects such as hygiene, production, quality control, and documentation.
This certification is a prerequisite for exporting medications to EU countries, enabling Renata to expand its exports to Europe, thereby creating a new revenue stream and enhancing foreign exchange earnings for Bangladesh. Achieving EU GMP compliance typically requires substantial investments in facilities, processes, and employee training, driving a company to elevate its overall operational standards.
The Rajendrapur unit had previously gained access to the UK market and received approvals from the US FDA, the World Health Organization, and the Brazilian Health Regulatory Agency.The audit by EU inspectors took place in February, and the company received its GMP Compliance certificate on Tuesday.
Currently, Renata’s annual export volume stands at approximately $25 million. “Our export volume is expected to rise as we gain easier access to the EU market,” stated Mr. Alam. The certification from EU authorities is also recognized by Latin American countries. “This will therefore ease our export processes to Latin American markets,” Mr. Alam further commented.EU GMP is regarded as one of the most esteemed quality standards worldwide. It bolsters Renata’s reputation among global partners, investors, and regulatory bodies.
Consequently, gaining access to the EU could result in new collaborations, increased stock valuations, and enhanced confidence from institutional investors. In the meantime, investors showed excitement as they drove up Renata’s shares, with the stock price rising by 0.39 percent to Tk 490.20 per share by the close of trading on the Dhaka Stock Exchange on Wednesday.
