ZIM Laboratories’ arm gets marketing authorization for Dimethyl Fumarate Capsules

20 Mar 2025 Evaluate

ZIM Laboratories’ wholly owned European subsidiary -- SIA ZIM Laboratories has received Marketing Authorization (MA) from Infarmed (Portugal) - the Portuguese National Authority of Medicines and Health Products for Dimethyl Fumarate (120 mg & 240 mg) Modified Release Capsules in Portugal. This authorisation will facilitate faster approvals in other European Union countries as well as the UK and other markets globally resulting in better commercialisation opportunities.

Dimethyl Fumarate Modified Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS) and are developed using ZIM’s proprietary technology and is bioequivalent to the Innovator’s product.

According to IQVIA, the EU market size for this product in 2023 was approximately $800 million while UK contributed $200 million. Other markets (Ex USA & Japan) contributed $42 million. 

ZIM Laboratories manufactures, formulates, and distributes drug delivery systems to develop generic pharmaceutical products.

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