Croma-Pharma GmbH Celebrates FDA Approval of Obagi saypha® MagIQ™ in the U.S. Market

Croma-Pharma GmbH Celebrates FDA Approval of Obagi saypha® MagIQ™

Croma-Pharma GmbH, a prominent name in minimally invasive aesthetic medicine, has reached an exciting milestone with the FDA's approval of Obagi saypha® MagIQ™, their first injectable hyaluronic acid filler designed for the U.S. market. This breakthrough signifies a major step in Croma's mission to expand globally and introduce innovative solutions in aesthetic treatments.

Announced on September 10, 2025, this approval paves the way for commercial launch in 2026 and highlights Croma’s collaboration with Waldencast plc under the Obagi Medical label. According to Andreas Prinz, CEO of Croma-Pharma, this achievement not only validates their advanced technology in hyaluronic acid but also reinforces their commitment to delivering high-quality products backed by scientific research.

Croma-Pharma has an impressive track record, having produced over 110 million syringes and establishing a presence in over 80 markets. The anticipation surrounding Obagi saypha® MagIQ™ stems from an essential study conducted in the U.S. involving 270 patients, which confirmed its effectiveness and demonstrated that it meets the safety and performance benchmarks set by the FDA. This study included a diverse array of Fitzpatrick skin types, showcasing its broad applicability.

The FDA’s validation of Croma's saypha® technology marks a pivotal moment not just for the company, but for the aesthetic industry as a whole. It sets the stage for a comprehensive expansion that includes additional products like saypha® ChIQ™, pending further regulatory approvals.

A Strategic Partnership

The strategic alliance between Croma-Pharma and Waldencast is aimed at revolutionizing the availability of aesthetic treatments in the United States. Waldencast, known for building reputable beauty and wellness brands, will be crucial in driving the launch and visibility of Obagi Medical’s offerings. The merging of Croma’s European innovation in hyaluronic acid with Waldencast’s U.S. market expertise underscores a substantial collaboration in the field.

As Croma-Pharma continues to amplify its global footprint, the company remains steadfast in its dedication to innovating within its portfolio, which comprises hyaluronic acid fillers, bio-stimulators, PDO threads, and botulinum toxin products. This commitment ensures that aesthetic practitioners are equipped with the necessary tools to deliver comprehensive treatment outcomes.

About Croma-Pharma GmbH

Founded in Leobendorf, Austria, Croma-Pharma GmbH is a family-owned business specializing in minimally invasive aesthetic solutions. With a robust production mechanism for hyaluronic acid syringes and an extensive product range, Croma serves the global market with cutting-edge treatments, including botulinum toxin and PDO threads.

About Waldencast

Waldencast, co-founded by Michel Brousset and Hind Sebti, aims to create a cutting-edge global platform for beauty and wellness brands, focusing on high-growth and conscious brands. Their strategy integrates operational excellence with brand development, ensuring a unique customer experience while maintaining the integrity of each brand.

About Obagi Medical

Obagi Medical is a leader in advanced skincare treatments, recognized for its innovative approach to issues like hyperpigmentation and premature aging. With over 35 years in the industry, the brand empowers individuals toward healthier, more beautiful skin through scientifically developed products.

This new FDA approval for Obagi saypha® MagIQ™ represents more than just a product launch; it reflects a significant development in the aesthetics field that promises to enhance patient care and treatment diversity across the industry. As Croma-Pharma gears up for its U.S. launch, the excitement in the market is palpable, heralding a promising era for aesthetic medicine.