17 November 2025
Humens Group secures China DMF for Pharma-Grade Sodium Bicarbonate
Humens Group is proud to announce the official approval of its Drug Master File (DMF) in China for its pharmaceutical-grade sodium bicarbonate manufactured at the Novabay site in Singapore, an API-GMP certified facility.
This strategic milestone strengthens Humens’ global presence in the high-quality pharmaceutical API market and demonstrates the company’s commitment to regulatory excellence.
The China DMF, approved on 10 October 2025 by the China CDE, enables Humens Group’s partners and clients to use Novabay’s pharmaceutical-grade sodium bicarbonate in the manufacturing of hemodialysis solutions and API formulations for the Chinese market, in full compliance with local regulations.
“Registering our DMF in China validates the international quality and compliance of our pharmaceutical-grade sodium bicarbonate. This milestone reflects the dedicated work carried out by our teams over the past three years to achieve this goal and marks an important step in the development of Novabay’s Pharma & Hemodialysis business”, said Véronique Toscan, Commercial Director of Humens Group.
This milestone follows Novabay’s CEP approval by EDQM in February 2024, further strengthening European and global regulatory compliance for its pharmaceutical-grade products.
The Novabay site is recognized not only by the majority of country regulators, but also by customers and market players for its operation excellence know-how, its high level of pharmaceutical and food certifications, and its high-purity products, widely used across the globe.
With the China DMF approval and EDQM CEP recognition, Humens Group reaffirms its dedication to providing safe, traceable, and fully compliant pharmaceutical-grade ingredients, supporting global health and well-being.
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