Soluplus^® is now listed as an “Activated” excipient on China’s Drug Master File (DMF)

May 2026: BASF Pharma Solutions is pleased to share an important regulatory milestone: Soluplus^®- published in the European Pharmacopoeia since July 2025 under the monograph title MACROGOL POLY(VINYL ACETATE)-POLY(VINYLCAPROLACTAM) GRAFTED COPOLYMER—has now been approved by China’s National Medical Products Administration (NMPA) as part of a bundling review with a finished drug.

Soluplus^® is now listed as an “Activated” excipient on China’s Drug Master File (DMF) platform under the following filing number:

            F20210000495 (A)

With this recognition, Soluplus^® is no longer considered a novel excipient for oral applications in Europe and China. Soluplus^® benefits from official Ph. Eur. and activated Chinese DMF status, allowing for simplified product development activities and regulatory submissions.

Soluplus^® at a Glance

Soluplus^® is a multifunctional pharmaceutical polymer designed to enhance the oral bioavailability of poorly soluble active pharmaceutical ingredients (APIs) Its unique amphiphilic structure enablessolubilization, making it an ideal choice for modern drug delivery systems.

Key Benefits:

• Enhanced Solubility: Improves dissolution and absorption of poorly soluble APIs, supporting bioavailability enhancement.
• Hot Melt Extrusion Ready: Offers excellent extrudability and smooth processing, ideal for continuous manufacturing.
• Matrix-Forming Capability: Enables the creation of stable amorphous solid dispersions (ASDs) for improved drug performance.

Access the Monograph and DMF

The official monograph is available for download via the European Pharmacopoeia Online (license necessary). The activated Chinese DMF number can be accessed via the Center for Drug Evaluation.

Learn More

Explore the benefits of Soluplus^® in our product brochure or request a sample to experience its performance firsthand.