Sovereign Pharma gains EU approval for aseptic and terminally sterilised injectable products
The company has invested an additional 30 million euros to upgrade its existing facilities and is set to be in line for production by the end of 2025
Sovereign Pharma, gains EU approval for aseptic and terminally sterilised products, including vials, ampoules, cartridges, and pre-filled syringes (PFS) for both liquid and lyophilized formulations. This achievement is a significant step in the company’s commitment to quality, safety, and global healthcare excellence.
In addition to the EU approval, ANVISA, the regulatory body under Brazil’s Ministry of Health, granted approval for aseptically processed and terminally sterilised small volume parenteral solutions. Likewise, the UK’s MHRA approved the company’s terminally sterilised small volume liquids for vials. These certifications, coupled with WHO-GMP certifications and many others (held since 2006), reinforce Sovereign Pharma’s dedication to time-tested and globally trusted manufacturing standards.
With an established footprint in over 50 countries, Sovereign Pharma aims to expand, leveraging these new approvals to penetrate additional markets. This milestone enables the company to manufacture both terminally sterilised and aseptically filled injectables, catering to the evolving needs of the global healthcare sector.
Sovereign Pharma has already begun upgrading its manufacturing facility to integrate Isolator lines, ensuring compliance with the latest technological and regulatory advancements. Furthermore, the company has invested an additional 30 million euros to upgrade its existing facilities. This investment includes the installation of isolator filling lines with auto lyophilised loading and unloading, fully automated packing lines, and the development of a dedicated building for PFS and cartridge filling that meets global standards. The facility is set to be in line for production by the end of 2025.