"Sovereign Pharma, part of Dadachanji Group of Companies and a leader in high-quality injectable manufacturing, received its European Union approval for aseptic and terminally sterilized products, including vials, ampoules, cartridges, and pre-filled syringes (PFS) for both liquid and lyophilized formulations.
The EU approval joins ANVISA (Brazil) and MHRA (UK) certifications, all three secured over the course of a year. With these three approvals, Sovereign Pharma has strengthened its global presence, ensuring its products meet the highest international regulatory standards. A Testament to Uncompromising Quality.
As part of its strategic approach, 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 Euro 30 million to upgrade its existing facilities. This investment includes the installation of isolator filling lines with auto lyophilised loading & 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.
Kairus Dadachanji, founder of Sovereign Pharma, said “This EU approval reaffirms our dedication to manufacturing excellence, ensuring that every vial, ampoule, cartridge, and syringe we produce meets the strictest levels of safety, efficacy, and reliability.” Global Regulatory Endorsements In addition to the EU approval, ANVISA, the regulatory body under Brazil’s Ministry of Health, granted approval for aseptically processed and terminally sterilized small volume parenteral solutions.
Likewise, the UK’s MHRA approved the company’s terminally sterilized 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, he added.
With an established footprint in over 50 countries, Sovereign Pharma is set to expand, leveraging these new approvals to penetrate additional markets. This milestone enables the company to manufacture both terminally sterilized and aseptically filled injectables, catering to the evolving needs of the global healthcare sector."