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
Andersen Consulting udvider sit udbud af humankapital med tilføjelsen af Jakarta Consulting Group16.1.2026 21:09:00 CET | Pressemeddelelse
Andersen Consulting styrker sine kompetencer gennem en samarbejdsaftale med Jakarta Consulting Group (JCG), der er et rådgivningsfirma, som er kendt for sin ekspertise inden for organisatorisk transformation, humankapitalstrategi og ledelsesudvikling. Med hovedsæde i Indonesien har JCG rådgivet virksomheder inden for brancher som ejendom, minedrift og produktion gennem strategisk og kulturel transformation. Med kerneydelser, der omfatter virksomheds- og administrationsrådgivning, hr-rådgivning, vurdering samt virksomheds- og ledelsestræning, er virksomheden kendt for sin evne til at transformere virksomheder og ledere med agilitet, kulturel intelligens og handlingsorienterede løsninger. "Vi har altid ment, at bæredygtig transformation begynder med mennesker – når ledere udvikler sig, følger organisationer med," siger Patricia Susanto, CEO for Jakarta Consulting Group. "Ved at kombinere Andersen Consultings globale perspektiv med vores regionale indsigt kan vi tilbyde kunderne mere helh
ClickHouse Raises $400M Series D Led by Dragoneer to Accelerate Expansion Across Analytics and AI Infrastructure16.1.2026 15:30:00 CET | Press release
Company acquires Langfuse to enter LLM observability and introduces a native Postgres service to unify transactional and analytical workloads ClickHouse, a leader in real-time analytics, data warehousing, observability, and AI/ML, announced today the close of its Series D financing, raising $400 million. The round was led by Dragoneer Investment Group, with participation from Bessemer Venture Partners, GIC, Index Ventures, Khosla Ventures, Lightspeed Venture Partners, accounts advised by T. Rowe Price Associates, Inc., and WCM Investment Management. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260116008883/en/ ClickHouse Co-Founders (left to right): Yury Izrailevsky, Aaron Katz, Alexey Milovidov The financing follows a period of sustained, accelerating growth for ClickHouse. The company now serves more than 3,000 customers on its fully managed service, ClickHouse Cloud, with ARR growing more than 250 percent year over year
Qualcomm Announces Quarterly Cash Dividend16.1.2026 15:00:00 CET | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on March 26, 2026, to stockholders of record at the close of business on March 5, 2026. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing busine
Nominations open for The MIDORI Prize for Biodiversity 2026 by AEON Environmental Foundation and the Secretariat of the Convention on Biological Diversity16.1.2026 09:00:00 CET | Press release
The MIDORI Prize recognizes outstanding individual contributions to the conservation and sustainable use of biodiversityThe unique prize contributes to raising public awareness of the essential role biodiversity plays for human well-being and in addressing global challenges such as climate changeThe Award Ceremony and Award Winners Forum will be held on 27 August 2026 in Tokyo, Japan The call for nominations for The MIDORI Prize for Biodiversity 2026 is open from 2 February to 31 March 2026. Nominations are invited from members of the public through the AEON Environmental Foundation website at https://www.aeonkankyozaidan.or.jp/en/prize/. The Award Ceremony and Award Winners Forum of the 2026 edition of the Prize will be held on 27 August in Tokyo, Japan. These events will contribute to the global mobilization around COP 17 of the Convention on Biological Diversity (CBD), which will take place in Yerevan (Armenia) under the theme of “Taking action for Nature”. Co-organized by the AEON
Tigo Energy and Weco Certify MLPE-Inverter Compatibility to Simplify PV System Design16.1.2026 06:00:00 CET | Press release
Tigo MLPE technology and hybrid inverters of Italian manufacturer Weco are now certified to work together to enhance design flexibility, system performance, and seamless integration. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced the Company has signed a certificate of compatibility with Weco S.r.l., documenting the compatibility between Tigo Flex MLPE products and hybrid solar inverters from Weco. The certification covers certain single-phase and three-phase Weco products and members of the Tigo TS4-A and TS4-X product families, when properly designed and installed. Together, these products are designed to deliver high-quality, enhanced value through a system that generates and manages solar energy more efficiently and delivers the features residential energy customers demand. “The compatibility between our inverter solutions and Tigo optimizers represents a significant step forward for the
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