Renata’s Mirpur facility earns Bangladesh’s first EU GMP

Renata PLC has achieved a historic milestone by securing European Union Good Manufacturing Practice (EU GMP) approval for its Potent Product Facility located in Mirpur.

This marks the first time a potent product facility in Bangladesh has received this prestigious certification, according to the press release of the company.

This new approval is expected to significantly expand Renata's ability to export potent products to highly regulated international markets, boosting Bangladesh's profile as a hub for high-quality pharmaceutical manufacturing, said the company in a press release.

The approval follows a rigorous inspection by the Competent Authority of Saxony-Anhalt (Landesverwaltungsamt Sachsen-Anhalt), the regulatory body representing Germany under the EU framework. The certification details are now officially listed on the Eudra GMP database, confirming compliance with the European Union's strict manufacturing and quality assurance standards.

Potent pharmaceutical products, often involving highly active ingredients at low dosages, require exceptional care in production. Manufacturing such products demands advanced containment systems, precise cleaning validations, and specialised protocols to prevent cross-contamination and ensure operator safety.

"With the certification, a new door has opened to the global market," said Jubayer Alam, company secretary of Renata PLC. "This is crucial for exporting potent products to European countries and will help Renata strengthen its global footprint."

"Now, we can easily export our products to EU countries, which will boost Renata's exports to Europe," he added.

With this latest certification, Renata PLC continues to demonstrate its commitment to global quality standards. The company's portfolio already includes approvals from several other Stringent Regulatory Authorities, such as the UK's Medicines and Healthcare products Regulatory Agency (UK-MHRA), the US Food and Drug Administration (US-FDA), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the World Health Organization Prequalification Programme (WHO-PQ), Health Canada, Australia's Therapeutic Goods Administration (TGA), and Brazil's ANVISA, read the press release.