CROMA-PHARMA-GMBH
8.7.2020 15:02:07 CEST | Business Wire | Press release
On July the 8th , Croma-Pharma GmbH (Croma) has stated that the company submitted the drug file of its botulinum toxin product to the German authority BfArM. The filing of the dossier stands for the next essential step towards Croma’s complete aesthetic portfolio in Europe, which already comprises of a comprehensive HA filler range, threads, PRP and skincare products.
Croma has licensed the product from the Korean toxin producer Hugel Inc. for Europe and established a joint venture company in 2018 with Hugel, Inc., in order to develop and commercialize Croma’s HA filler products together with Hugel’s botulinum toxin product in the US, Canada, Australia and New Zealand.
The filing to BfArM marks the first milestone in Croma’s approach to a European wide regulatory approval.
“We are pleased to announce that our toxin has finally been submitted – since quite some time hence, a European company will launch a botulinum toxin, which makes us both, happy and proud. Combining our present product and service offering with the last “missing link” will definitely boost our business and will have a feelable impact not only on our marketing and sales approach, but for sure also on our corporate culture.”, CEO Andreas Prinz points out in a first statement.
Croma’s botulinum toxin submission in Europe is based on 2 completed randomized, placebo-controlled Phase III pivotal trials (BLESS I and II) that enrolled a total of 917 subjects in Europe and the US. A third confirmatory pivotal trial to support the US submission (BLESS III) is currently ongoing in sites in Europe and the US and has completed its interim analysis after all 355 patients completed their visits for the primary endpoint.
About Croma-Pharma GmbH
Founded in 1976, Croma-Pharma GmbH (Croma) is an Austrian family-owned company that specializes in the industrial production of hyaluronic acid syringes for the fields of medical aesthetics, ophthalmology and orthopaedics. Croma currently runs 12 international sales companies and distributes its products in more than 70 countries. Within its global sales network, Croma focuses with own branded products on minimally invasive aesthetic medicine. Besides a broad range of HA fillers from the own production site, Croma markets PDO lifting threads, a Platelet Rich Plasma (PRP) system and a personalized skincare technology in its core strategic markets.
About Hugel, Inc:
Established in Korea in 2001, Hugel is a global leader in medical aesthetics providing botulinum toxin formulation BOTULAX / LETYBO, HA filler The CHAEUM / DERMALAX, and derma cosmetic WELLAGE / PR4 brands. Dedicated to provide proven, high quality medical aesthetic solutions that satisfy both consumers’ and practitioners’ needs, Hugel is leading Korean market for both botulinum toxin and HA filler products and is distributing its products to over 40 countries. Visit: www.hugel.co.kr
View source version on businesswire.com: https://www.businesswire.com/news/home/20200708005060/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Reply Signs Strategic Collaboration Agreement with AWS to Accelerate AI-Driven Cloud Transformation2.4.2026 10:00:00 CEST | Press release
Reply [EXM, STAR: REY] announced today that it has signed a strategic collaboration agreement (SCA) with Amazon Web Services (AWS) to accelerate the adoption of cloud and artificial intelligence solutions across key international markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260402597802/en/ This strategic collaboration agreement further reinforces Reply’s commitment to enable organizations across industries to harness the full potential of cloud and artificial intelligence technologies. At the core of the SCA is a strong focus on Artificial Intelligence and Generative AI. Leveraging the deep expertise of its specialized companies - Comsysto Reply, Data Reply, Sense Reply, and Storm Reply - Reply supports organizations in designing and deploying enterprise-grade GenAI solutions, including agentic AI systems for autonomous workflows, domain-specialized models for vertical industries, and governance frameworks aligne
Bending Spoons renews tech scholarship for women with €100,000 commitment2.4.2026 09:11:00 CEST | Press release
Bending Spoons today opened applications for the 2026 edition of its Women in Computer Science Scholarship. The program offers twenty scholarships, each worth €5,000, to university students pursuing technology degrees across Europe and the United Kingdom. This year’s recipients will also be invited to a two-day networking event in Milan in October, fully covered by the company. The initiative is part of a broader set of programs Bending Spoons runs to recognize and support the next generation of technology talent, including merit-based scholarships, networking events, and student competitions. "The students of computer science today will define what the field looks like in the years ahead," said Eva Milenkovska, talent manager at Bending Spoons and lead of the scholarship initiative. "This scholarship is about recognizing the women who are pushing themselves to excel and to help shape the future of the industry." This is the fourth time Bending Spoons has offered this specific scholars
SecurityTech on the Rise: G+D Reports Strong Order Intake and High Resilience in 20252.4.2026 08:30:00 CEST | Press release
In fiscal year 2025, Giesecke+Devrient (G+D) reaffirmed its position as global leader in SecurityTech for mission-critical infrastructure. In a market where security is becoming essential for technological and societal stability, G+D demonstrates strong growth prospects. In 2025, G+D achieved a record order intake of €3.6 billion (+8%). Revenue increased to €3.2 billion (+1%), although exchange rate effects dampened growth. The key figures underscore the company's strong operational performance and profitability: Adjusted EBIT reached a new high of €211 million. The substantial free cash flow of €119 million provides additional leeway for future investments. With its equally strong segments – Digital Security, Financial Platforms and Currency Technology – G+D boasts a resilient portfolio that effectively cushions market volatility. The company's success reflects this strategic strength, combining technological depth, a global presence and operational reliability. G+D is making targeted
Bona Releases 2025 Sustainability Report2.4.2026 08:05:00 CEST | Press release
Bona®, a global, family-owned company that supplies products for installing, renovating, maintaining, and restoring premium floors, has published its 2025 Sustainability Report. The report outlines progress across Bona’s three sustainability pillars – Respect our Planet, Care for People, and Trusted Business – and highlights the continued integration of sustainability into all aspects of its operations. “Our business is built on extending the life of existing flooring materials and reducing the need for replacement,” says Lidija Broström, Interim Chief Executive Officer at Bona. “At Bona, we are making steady progress in reducing our impact while building a stronger foundation for the future. By working closely with our partners, we aim to drive meaningful change across our value chain and contribute to a more sustainable future.” In 2025, Bona reduced total Scope 1 and 2 greenhouse gas emissions (market-based) by 46% compared to its 2022 baseline, reaching 1,338 tonnes of CO₂—surpassi
The Estée Lauder Companies Fully Establishes Its “One ELC” Operating Model and Reaches Milestone in Its Profit Recovery and Growth Plan1.4.2026 23:00:00 CEST | Press release
WPP Appointed First-Ever Global Media Partner, Unifying Media Execution Worldwide“One ELC” Operating Model Is Transforming How the Company Operates at Scale The Estée Lauder Companies Inc. (NYSE: EL) today announced WPP as its first-ever global media partner, marking a significant advancement of its One ELC operating model, a scalable system designed to operate faster, execute with greater discipline, and drive growth. In fully establishing One ELC, the Company also reached a significant milestone in its Profit Recovery and Growth Plan’s (PRGP) Restructuring Program — a key action plan priority of Beauty Reimagined. Stéphane de La Faverie, President and Chief Executive Officer, The Estée Lauder Companies, said, “With the appointment of WPP as our first-ever global media partner, our One ELC operating model is now fully established. This more unified and scalable system will enable us to be faster, more agile and efficient, and support unlocking additional growth. Together with our exec
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom