Today Skin Care Pharma GmbH announces the successful submission of the Marketing Authorisation application of its product Skinatan® cream, the first generic version of the originator product Advantan® (active substance: Methlyprednisolone aceponate) to the South African competent local authority SAHPRA (“South African Health Products Regulatory Authority“). Submission was made successfully under the responsibility of Abex Pharmaceutica (Pty) Ltd., the commercial partner of Skin Care Pharma in South Africa and Australia.
Skin Care Pharma and Abex Pharmaceutica entered into a mutually exclusive partnership Agreement for the registration and commercialization of Skinatan® formulations in South Africa and Australia in 2020.
After the submission of the Skinatan® Cream Marketing Authorisation Applications in certain European countries, South Africa is the first country outside of Europe, where the cream formulation has been presented to the regulatory authorities for assessment of approvability.
Ed Hallam, Chief Executive Officer of Abex comments: “Once Abex has been granted approval for the Skinatan® product range, it will create an opportunity for us to bring a new high quality cost effective generic option into the hands of health care practitioners, this will increase access and improve the quality of lives of South African patients living with eczema. South Africa represents a growing market where the prevalence of atopic dermatitis ranges from between 4.7% of the adult population to approximately 23% in children who suffer from this skin condition. This opportunity is fully in line with our objectives to strengthen key therapeutic areas, and we are looking forward to expanding our partnership with Skin Care Pharma with exciting new projects.”
Sven Schimansky-Wabra, Chief Executive Officer of Skin Care Pharma adds: “Congratulations to the whole Abex team for achievement of this important milestone in South Africa. The ongoing submission process in South Africa starts a series of registrations for Skinatan® in further countries in the coming months.“
Abex Pharmaceutica (Pty) Ltd is a South African-based international healthcare company involved in the development, manufacturing, registration, and commercialisation of prescription and over-the-counter pharmaceuticals which have been clinically proven to meet international standards. The company is recognised globally for its networks and excellence in service, reliability, high quality, effective and innovative healthcare solutions. Abex is a privately owned, family business, with headquarters and operational focus in South Africa; as well as international B2B operations in the United Kingdom, Australia, New Zealand, China and selected countries across MENA and LATAM geographies.
About Skin Care Pharma, part of the DERMAGO Group:
Skin Care Pharma GmbH is part of the DERMAGO Group, with headquarters in Strausberg, Germany.
DERMAGO is a service company that has been specializing in the development of unique generic versions and originator preparations of prescription, reimbursable dermatological pharmaceuticals and in independently advancing these through the pharmaceutical approval process. The services of DERMAGO also include consulting activities, scientific assessments, the preparation of expert reports as well as qualitative and quantitative studies especially for dermatological pharmaceuticals. The development of analytical methods and procedures as well as services for obtaining marketing authorization for pharmaceutical products are also part of the range of the company’s activities.