Big Win for MedPharm at CPhI Pharma Awards 2019
November 7, 2019
MedPharm has been named the winner in the Analysis, Testing, and Quality Control category at the prestigious CPhI Pharma Awards 2019. The annual awards provide recognition to those who turn inspiration into innovation within the pharmaceutical industry.
MedPharm’s win comes as a direct result of its efforts in pioneering and refining new approaches to demonstrate the bioequivalence of topical generic products in regulatory submissions.
Eugene Ciolfi, President and CEO of MedPharm, commented: “This award is a testament to MedPharm’s depth of experience and integrity in the field of in vitro modeling and topical formulation development.
“By refining and automating these in vitro models MedPharm has created a cost-effective route to demonstrating bioequivalence.”
Both the EMEA and FDA have recently recognized that the approval of topical generic products has been hampered by their demand to demonstrate bioequivalence in the clinic. These clinical trials are expensive and risky which has created a major barrier to generic entry. MedPharm has worked with the regulatory authorities to develop sophisticated in vitro models and robust statistical justification using multiple donors to demonstrate bioequivalence.
The company’s recent double-digit top-line growth can be attributed to the demand for these specialist services. The ultimate winner is the patient who can benefit from a more cost-effective topical therapy.
NOTES TO EDITORS
MedPharm is the world’s leading contract provider of topical and transdermal product design and formulation development services. MedPharm is experts at reducing risk and accelerating development times for generic and proprietary pharmaceutical customers through their unique, cost-effective and industry-leading performance testing models. Well established as the global leaders in dermatology, nail, mucosal membrane, and transdermal product development, MedPharm can also offer innovative solutions for ophthalmic and airway preparations recognised for their scientific rigour by regulators and investors. MedPharm has fully established Centers of Excellence in the USA and UK.