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Through this choice of new partner AcuCort ensures a high quality, experienced and cost-effective performer of the bioequivalence studies who can help us with one of the most important steps towards market approval, according to the schedule that we have communicated.
Mats Lindfors, CEO of AcuCort
Dexa ODF is now another step closer to a registration application.
Mats Lindfors, CEO of AcuCort AB
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AcuCort confirms response from the Swedish MPA regarding ISICORT® market application

AcuCort AB (Spotlight Stock Market: ACUC) has received the Primary Round Assessment Report from the Swedish Medical Products Agency (MPA), in response to the national Market Authorization Application (MAA) for ISICORT® in September 2019. The company is currently reviewing the report and preparing answers. No significant obstacles have been identified. No major objections towards an approval have been raised by the MPA.As reported on September 30[th] 2019, AcuCort AB has submitted a national hybrid application for approval of the company’s drug candidate ISICORT® to the Swedish Medical

AcuCort’s allergy medicine Dexa ODF has been manufactured and released according to Good Manufacturing Practice, GMP

AcuCort AB (Spotlight Stock Market: ACUC) today announces that the company’s manufacturing partner Adhex Pharma has manufactured and released three batches of AcuCort’s allergy medicine, the fast-dissolving oral film Dexa ODF, according to Good Manufacturing Practice, GMP. Production according to GMP is an important milestone in the development plan. The batches will be used in the planned bioequivalence studies that later will form the basis for the application for product registration of Dexa ODF firstly in the EU.Since May 2017AcuCort has collaborated with its manufacturing partner Adhex

AcuCort’s allergy treatment Dexa ODF is ready to be manufactured according to GMP (Good Manufacturing Practice) for clinical use

AcuCort AB (AktieTorget: ACUC) today announces that the company has finalized the scaling-up of the manufacturing process for its drug candidate, the fast-dissolving oral film Dexa ODF to be placed on the tongue for the treatment of acute allergic reactions, and thereby is ready for manufacturing according to GMP (Good Manufacturing Practice) for clinical use in preparation of planned registration applications.Since May 2017, AcuCort has collaborated with the manufacturing partner Adhex Pharma with the goal to establish a manufacturing process for Dexa ODF that meets the requirements for

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