Magle Chemoswed has acquired Adroit Science AB, a specialist solid state company based in Lund, Sweden. The acquisition strengthens Magle Chemoswed’s offering of integrated contract development services as well as innovation and product development capability and capacity. We are excited to welcome the former Adoit team (now Solid State) to the Magle Chemoswed family.
We are happy to announce that Magle Chemoswed has successfully gone through an annual audit of its ISO 13485:2016 quality system for the development and manufacturing of medical devices. The scope of the extended Quality Management system covers: Design, development, manufacture and distribution of active pharmaceutical ingredients and medical devices. Magle Chemoswed continuously maintains a valid good manufacturing practice certification alongside the ISO 13485:2016 accreditation.
Magle Chemoswed has been fatured in Dagens Industri as a part of the Almedalsveckan supplement. Click below to read the full article (in Swedish).
The Quality Management System of Magle Chemoswed har been transformed from a traditional GMP system to a bilingual system also addressing the requirements of ISO 13485:2016 for Medical devices. After passing a successful onsite audit the ISO 13485 certification was granted on April 28, 2019 by the Notified Body CE Certiso, NB 2409.
The scope of the extended Quality Management system covers:
Design, development, manufacture and distribution of active pharmaceutical ingredients and polysaccharide based medical devices.
Magle Chemoswed continuously maintains our GMP certification.
As a part of the efforts to modernize, Magle Chemoswed has invested in new modular facilites to be placed on the production facility site. We are happy to announce that planning permission has been granted by Malmö Stad and that our move from the Celsiusgatan facilites will move forward as planned. The new facliites mean that the company will now be gathered to one site, making all our operations smoother and more focused.
Magle Chemoswed has received positive responses from regulatory agencies for market authorization of its range of advanced wound care products. This provides us with a clear pathway to registration of these developed products. As a strategic market for the Company this is an exciting and welcome development. The first line of products are expected to filed within Europe and the United States in the latter parts of 2018.
Magle Chemoswed expands its sales of Benserazide to a key customer as part of the Company strategy to enter emerging markets. The sale of Benserazide is testament to our strong commitment to make a difference in the field of healthcare and responsibly expanding our business to new and exciting markets.
Magle Chemoswed has filed multi-jurisdictional patent applications for protection for our range of surgical diagnostic devices. This is a first-in-class invention under which we have chemically bound enzymatic indicators to our SmartSpheres to be used by surgeons following suturing to identify enzymatic leakage.
MCS receives approval from the United States patent authorities on its microsphere technology
MCS’s SmartGel successfully moves to final phase for testing before regulatory approval.