Croma-Pharma has obtained marketing authorization in Spain for its botulinum toxin from the Spanish Agency for Medicines and Health Products (AEMPs), after having completed all the efficacy and safety requirements demanded by the European Medicines Agency - EMA) during the first quarter of this 2022. For this, the company presented a complete dossier of 3 clinical trials carried out on more than 1,000 patients in Europe and the United States. According to the magazine Belleza Médica, the license of the product for Europe was made through the Korean toxin manufacturer Hugel Inc. In 2018, Croma already established a joint venture with Hugel in order to develop and market hyaluronic acid filler products and the botulinum toxin internationally for the American market (United States and Canada), Australia and New Zealand.
Croma's botulinum toxin is not only suitable for the treatment of glabellar wrinkles (between the eyebrows) in Spain, currently the company also has approval in 10 other European countries such as Germany, Austria, France, Italy, Ireland, United Kingdom, Netherlands, Poland, Portugal or Romania.
“We are proud to be the first Austrian family company to launch its own neurotoxin on the aesthetics market. In the coming weeks and months, we expect other European countries to give their national approval”, says its CEO Andreas Prinz.
For María Cudeiro, CEO of Croma in Spain and Portugal, "it is a before and after in the history of Croma-Pharma, we became a pharmaceutical laboratory. With the addition of our own botulinum toxin to the already extensive portfolio, we catapulted ourselves to a new level within the aesthetic industry".