FDA Bioequivalence (BE) approval for the IVPT study conducted on Penciclovir Cream 1%
Diteba Inc. has received FDA Bioequivalence (BE) approval for the IVPT study conducted on Penciclovir Cream 1%. The IVPT method is an essential biowaiver tool for evaluating bioequivalence in generic dermal and transdermal products.
Over 20 years, Diteba has successfully assisted many of its pharmaceutical clients with their ANDA submissions through our expertise in IVRT and IVPT studies, in accordance with the latest FDA guidance from October 2022. This recent approval is another affirmation of Diteba’s commitment to excellence and our leadership in transdermal science.
For further information on these and other industry-leading capabilities, please contact our Professional Sales Team or email info@diteba.com.
