CROMA-PHARMA-GMBH
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
Duravant Announces Retirement of CEO Mike Kachmer, Names Jill Evanko Successor17.11.2025 16:13:00 CET | Press release
Mike Kachmer to retire following a distinguished 43-year career, including nearly 12 years as Chairman & CEO of Duravant Jill Evanko to succeed Mr. Kachmer as Duravant’s Chief Executive Officer Duravant LLC (“Duravant”), a global leader in advanced automation solutions, announced today that Mike Kachmer will retire from his role as Chief Executive Officer after a highly successful tenure with the company. Duravant’s Board of Directors has named Jill Evanko as CEO, joining the company on January 5, 2026. To ensure a seamless transition, Mr. Kachmer will continue to serve as Chairman of Duravant. Mr. Kachmer will also continue to serve on the Board of Directors for Northwestern Memorial Healthcare and The London Clinic. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117036720/en/ Mike Kachmer “It has been a true honor and a humbling experience to lead this incredible company,” said Mr. Kachmer. “I am profoundly grateful to
Wolters Kluwer Enablon Control of Work Solution Now Available as Private Offer in AWS Marketplace17.11.2025 15:00:00 CET | Press release
Wolters Kluwer today announced that its Enablon Control of Work solution is now available in AWS Marketplace as a private offer. This purchasing model empowers customers to negotiate and receive tailored pricing, terms, and licensing agreements, while streamlining procurement and leveraging existing Amazon Web Services (AWS) billing workflows to accelerate deployment and optimize cloud budgets. Wolters Kluwer’s Enablon Control of Work solution consolidates permit-to-work, isolation management and risk assessments into an integrated system. Trusted by frontline workers and contractors in high-risk environments including oil & gas, pharmaceuticals, data center and manufacturing industries, the software helps streamline operations, minimize unplanned downtime and prevent serious injuries and fatalities. Richard Pulliam, SVP & General Manager of EHS & ESG for Wolters Kluwer, said: “Making Enablon's Control of Work solution available in AWS Marketplace is another step in our mission to help
Morningstar's 2026 Outlook Report Delivers Global and Regional Insights for Durable Portfolios17.11.2025 15:00:00 CET | Press release
Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment insights, today published its 2026 Outlook, offering an overview of key challenges and opportunities for the year ahead. In a market defined by uncertainty, this year’s report emphasizes the value of preparation over prediction, equipping investors with strategies to focus on fundamentals and help build resilient portfolios that withstand both booms and busts. Drawing on insights from Equity, Manager, and Behavioral research analysts worldwide, this Outlook distills Morningstar’s thinking on how to navigate opportunity and risk across every major asset class in 2026. "Markets are unpredictable, and the geopolitical and tariff uncertainty of 2025 showed just how quickly forecasts can shift. That’s why Morningstar is redefining the Outlook, focusing on durable portfolios rather than short-term predictions,” said Dan Kemp, chief research and investment officer. “No matter what market conditions the year ahead m
World First: Autonomous Racing Leaps Forward in Abu Dhabi as A2RL Season 2 Showcases Record Speed, Bold Overtakes and Real-Time AI Decision-Making17.11.2025 14:50:00 CET | Press release
TUM Retains Crown as A2RL Delivers World’s First Six-Car Autonomous Grand Final Eleven international teams competed for $2.25 million prize pool Human vs AI: Former F1 star Daniil Kvyat stayed just ahead of the autonomous challenger’s time; for now, human drivers still hold a slight edge Watch the race here: https://youtu.be/d9LLZ5mb5cA?si=RgJnvjWhdasZdXZS The Abu Dhabi Autonomous Racing League, A2RL, delivered a defining moment for autonomous technology as six fully driverless racecars pushed the limits of AI performance in a world-first Grand Final at Yas Marina Circuit. In a night marked by record speed, bold overtakes, and split-second AI decision-making, Germany’s TUMcemented its dominance by retaining the championship title, followed by TII Racing (UAE) in second place, and PoliMOVE (Italy) in third. With eleven international teams battling for a $2.25 million prize pool and a Human vs AI showdown featuring former F1 star Daniil Kvyat, the event showcased just how dramatically th
87% of Institutional Investors Have Declined or Reconsidered Fund Commitments Due to AML/KYC Concerns17.11.2025 14:30:00 CET | Press release
63% of GPs say they have lost investors or reinvestments due to AML/KYC compliance shortcomings88% of LPs are more likely to invest in a manager with a formal AML/KYC programNearly three-quarters of GPs report cost savings of 10-30% from outsourcing AML/KYC functions to dedicated specialists Nearly nine-in-10 (87%) limited partners (LPs) have declined or reconsidered a fund allocation due to anti-money laundering and Know Your Customer (AML/KYC) concerns, underscoring just how significant compliance has become as a gatekeeping item for fundraising. According to a new study by CSC, the leading provider of global business administration and compliance solutions, general partners (GPs) are already feeling the strain. Almost two-thirds (63%) report losing investors or reinvestments due to AML/KYC shortcomings, most commonly from documentation gaps (61%) and onboarding delays (24%). CSC surveyed 200 GPs and 200 LPs across North America, Europe, the U.K., and Asia Pacific to capture views on
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