
ZIM Laboratories Receives Marketing Authorization for Dimethyl Fumarate Capsules in Portugal, Europe
ZIM Laboratories Limited has announced that INFARMED (Portugal) has granted Marketing Authorization for its Central Nervous System (CNS) product 'Dimethyl Fumarate 120 mg & 240 mg Modified Release Capsules' in Portugal. This authorization will facilitate faster approvals in other European Union countries, the UK, and other markets globally, offering better commercialization opportunities. The product, developed using ZIM’s proprietary technology, is bioequivalent to the Innovator’s product and indicated for the treatment of relapsing forms of multiple sclerosis (MS). As per IQVIA, the EU market size for this product in 2023 was approximately USD 800 MN, while the UK contributed 200 MN USD and other markets (excluding USA & Japan) contributed 42 MN USD.
Key Highlights
- ZIM Laboratories Limited receives Marketing Authorization for Dimethyl Fumarate 120 mg & 240 mg Modified Release Capsules in Portugal, Europe.
- Faster approvals expected in other European Union countries, the UK, and other markets globally.
- Product developed using ZIM’s proprietary technology and is bioequivalent to the Innovator’s product.
- Indicated for the treatment of relapsing forms of multiple sclerosis (MS).
- EU market size for this product in 2023 was approximately USD 800 MN, with UK contributing 200 MN USD and other markets contributing 42 MN USD.