#FDA Approval #Austria #Hyaluronic Acid #Croma-Pharma #Leobendorf

Croma-Pharma Achieves Landmark FDA Approval

Croma-Pharma GmbH, a family-owned enterprise based in Austria, has recently achieved a significant milestone in the realm of aesthetic medicine by securing FDA approval for its groundbreaking hyaluronic acid filler, Obagi saypha® MagIQ™. This achievement places Croma-Pharma in an exclusive group as only the second Austrian company to receive such authorization from the U.S. Food and Drug Administration.

The FDA's endorsement not only paves the way for Croma-Pharma's entry into the U.S. market in 2026 but also showcases the fusion of Austrian innovation with American brand recognition through its collaboration with Obagi Medical, which is part of the esteemed Waldencast Group. The aim is to set new standards in combined aesthetic solutions that are both innovative and reliable.

Andreas Prinz, the CEO of Croma-Pharma, emphasized the significance of this approval, stating, "This FDA approval marks not just a milestone for Croma, but also elevates the entire Austrian pharmaceutical sector. It validates our commitment to high-quality technological solutions and our dedication to developing secure and innovative products for healthcare professionals and patients worldwide."

Obagi saypha® MagIQ™ is built on Croma's proprietary MACRO Core Technology™, which creates a stabilized three-dimensional matrix of hyaluronic acid with high density. This advanced formulation allows for even distribution, controlled injection properties, and natural, long-lasting results that are crucial for aesthetic treatments.

The FDA approval was granted based on extensive research involving a U.S. regulatory study that included 270 participants treated for nasolabial folds. This study successfully met both primary and secondary endpoints, demonstrating excellent safety and efficacy profiles across a diverse range of skin types.

Croma-Pharma has a robust history in the field, with over 110 million hyaluronic acid syringes produced and decades of experience in the aesthetic medicine sector. Prinz stated further, "Our goal is to contribute to the peak of aesthetic medicine—scientifically backed, safe, and effective. The FDA approval not only grants us access to the largest aesthetic market in the world but also affirms our international competitiveness."

Following the U.S. launch of Obagi saypha® MagIQ™, Croma-Pharma plans to introduce additional products from the saypha® line, including saypha® ChIQ™, pending further FDA approvals.

About Croma-Pharma GmbH

Founded in 1976, Croma-Pharma GmbH is a family-run, global player in the field of minimally invasive aesthetic medicine. With headquarters in Leobendorf, Austria, the company specializes in the industrial production of hyaluronic acid injections and distributes its range of products in over 80 countries. The portfolio includes HA fillers, botulinum toxin, PDO threads, and biostimulators, aiming to provide innovative solutions in aesthetic enhancements.