ZIM Laboratories receives marketing authorization for Dimethyl Fumarate in Portugal

Dimethyl Fumarate Modified Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis

ZIM Laboratories has announced that INFARMED (Portugal), the Portuguese National Authority of Medicines and Health Products,  has granted Marketing Authorization (MA) for ZIM's Central Nervous System (CNS) product "Dimethyl Fumarate 120 mg & 240 mg Modified Release Capsules," in Portugal to its wholly owned European subsidiary, SIA ZIM Laboratories Limited.

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 US$ 800 million while UK contributed US$ 200 million. Other markets (Ex USA & Japan) contributed US$ 42 million.