Renata’s Mirpur factory gets EU approval

Renata PLC, one of the leading pharmaceutical companies in Bangladesh, has secured European Union Good Manufacturing Practice (EU GMP) approval for its Mirpur potent product facility.

In a press release issued today, Renata said this is the first EU GMP-approved potent product facility in Bangladesh.

In the pharmaceutical industry, a potent product facility is a specialised plant designed for the safe manufacturing of highly potent drugs, which require exceptional precision due to their high potency and low dosage needs.

These products demand stringent cleaning validation protocols, advanced containment systems, and specialised handling procedures to prevent cross-contamination.

The approval was granted following an inspection by the German regulatory authority (Competent Authority of Saxony-Anhalt, or Landesverwaltungsamt Sachsen-Anhalt).

The full certification details are available on the Eudra GMP website.

This recognition adds to Renata's existing portfolio of approvals from stringent regulatory authorities, including the UK-MHRA, US-FDA, PIC/S, WHO-PQ, Health Canada, TGA, and ANVISA.