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Andrea Confetti, Exclusive Synthesis Business Unit LeaderAs a third-generation family-owned company, it draws upon its rich legacy of stability, commitment, and financial solidity to deliver on innovation by proactively identifying and fulfilling clients’ needs. Backed by over 70 years of industry experience, it develops innovative synthetic processes using state-of-the-art technologies and safely handles hazardous chemical processes, serving as a partner of choice for clients seeking synthesis services. Its turnkey services cover the entire lifecycle of a molecule, from the discovery phase to commercial release.
“The basis of our value proposition is the ability to strike a perfect balance between trust, reliability, and experience,” says Andrea Confetti, exclusive synthesis business unit leader at Dipharma.
Dipharma operates as an extension of a client’s teams and builds trusted partnerships with them to help speed up critical phases of their clinical development projects to align with timelines. Its dedicated project team ensures transparent communication of potential issues and opportunities regarding the project’s progress. A strong background in project management and communication skills helps in guaranteeing the successful introduction of a new product to the market.
With a knowledgeable regulatory affairs department, it thoroughly understands the everevolving regulations of the European Medicines Agency, the U.S. Food & Drug Administration, and Pharmaceuticals and Medical Devices Agency, Japan.
“We possess the relevant knowledge, equipment, and attitude to anticipate and address client requests,” says Confetti.
Dipharma has a keen focus on sustainability. It has installed a cogeneration system in its Caronno plant and a trigeneration unit in its Mereto plant to increase energy efficiency and reduce carbon dioxide emissions by over 3,000 tons every year. It recently earned the silver rating from EcoVadis for its efforts in developing and improving green processes.
Leveraging a skilled R&D team and an internal intellectual property (IP) department, Dipharma strengthens its value proposition and competitive edge by enabling customers in protecting innovations with IP rights. Clients are also provided with non-infringement advice on the overall patent landscape.
The basis of our value proposition is the ability to strike a perfect balance between trust, reliability, and experience
Dipharma identified ideal conditions to manufacture the compound in large quantities and devised a suitable way to convert the liquid into a solid by forming a salt. As the molecular weight of the salt was higher, the compound was more stable and allowed for safe transportation.
“We are constantly ramping up in the pharmaceutical space, and the repeat business we are witnessing is a testament to our success. We are neither too big to become rigid in interacting with clients nor small to miss opportunities. We continue to support our clients every step of the way,” says Confetti.
Company
Dipharma
Management
Andrea Confetti, Exclusive Synthesis Business Unit Leader
Description
Dipharma is a global CDMO and a leading manufacturer of active pharmaceutical ingredients (API) and intermediates. It serves top-ranking pharmaceutical companies in Europe, the U.S.A., and Japan.
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Chiasso, Switzerland and Reading, England - Dipharma SA (“Dipharma”) and LogixX Pharma (“LogixX”) are pleased to announce that the Medicines and Healthcare Products Regulatory Agency (“MHRA”) has granted Marketing Authorization for their generic product Sapropterin Dihydrochloride (“Sapropterin”).
Sapropterin Dihydrochloride is a pharmaceutical product that serves as a generic alternative to Kuvan®. It can be obtained in the market in the form of soluble tablets with a strength of 100mg. Additionally, it is also introduced in the United Kingdom with a new presentation: powder for oral solution, available in strengths of both 100mg and 500mg.
“After the approval we received by Swissmedic and the European Medicine Authority, we are pleased to announce that also the MHRA has now approved our Sapropterin in all the available dosages and formulations for the UK market” - said Marc-Olivier Geinoz, CEO of Dipharma – “We achieved this result thanks to the collaboration between Dipharma and our UK partner LogixX. British patients will benefit by having access, for the first-time, to a sapropterin dihydrochloride product now also available in powder formulation. Sapropterin should be placed in a glass or cup of water and stirred until dissolved, an operation which typically takes several minutes. With Sapropterin powder formulation, this operation is performed in a matter of seconds, which is expected to have a positive impact on treatment compliance and quality of life. This approval, along with the imminent launch of our sapropterin products in the European Union, reinforces our aim of bringing additional value to patients, coupling this with sustainability principles for National Healthcare System.”
Dipharma and LogixX are planning to launch the product into the UK market in the third quarter of 2023, shortly after the launch in Europe.
LogixX Pharma's C.E.O. Michael Close said "there is great synergy between both companies. This opportunity combines Dipharma’s expertise in developing and manufacturing rare and metabolic disease treatments and LogixX Pharma’s expertise in launching novel and rare disease pharmaceuticals to the UK market. This partnership strengthens LogixX’s own mission to bring new therapies to patients, new treatment approaches for healthcare professionals and better health outcomes for all”.