Nesvik Pharmaceuticals Goal
Nesvik Pharmaceuticals, Inc. is a science-driven organization focused on developing Rx & OTC products in the forms of liquids, semi-solids, and topicals for either sample distribution or commercialization. We aim to succeed in every aspect of R&D while complying with FDA requirements. Furthermore, we execute diligently on validating all products that are manufactured within our USA facility. Whether you need us to do a pilot batch for non-commercial use or for sale, we can meet your needs by offering a customized package for both product development and manufacturing under one location. One of the main focus points within our R&D Department is continuing to take on product development projects that are complex and potentially are offered under licensing/exclusivity agreements with long-term profit sustainability’s.
Our organization continues to invest in resources in order to better serve our customers and we continue to add into our pipeline new and existing formulas. Moreover, we continue to offer new and existing formulas so that our customers can benefit in diversifying their product portfolio and further increase their sales, especially on niche products (NDA’s/ANDA’s/ OTC’s).
Product Development, Rx & OTC Services
Below are some of our services we offer within Product Development, Rx & OTC:
Formulation Development Pilot Batches (Commercial or Non-Commercial)
Accelerated, Intermediate and Long-Term Stability Studies (ICH Guidelines)
Complete Release Testing for pilot and commercial size batches
Product Development for NDA’s / ANDA’s / OTC’s
Product Development for Liquids, Solids & Topicals
Process Validations & Cleaning Validations
Protocols for execution
NDA & ANDA Submission Filings
Nesvik Pharmaceuticals is working at the forefront the pharmaceutical industry to reformulate traditional solid dosage drugs into liquid delivery methods for niche patient groups using the FDA’s 502(b)(2) accelerated pathway to the market.
There are many challenges when trying to treat the pediatric and geriatric segments of the population with solid dosage drugs. Children and the elderly often experience difficulties in swallowing solid dosage drug forms. In both patient groups, small sized particulates or liquid dosage forms are superior to classic tablets or capsules. This creates a niche market for drug manufacturers like Nesvik Pharmaceuticals to take advantage of.
The 505(b)(2) Accelerated Development Path
In order to assist companies to develop and deploy liquid form drugs quickly, the FDA has created an accelerated approval process called 505(b)(2) process. This process allows reformulation companies to leverage prior drug data and trial information from the original drug manufacturer of the solid form. This new pathway alleviates additional lengthy, expensive trials. From beginning to end a drug candidate can fast track into the market in approximately 24 to 30 months.
Targeted for Reformulation
Currently, Nesvik Pharmaceuticals has chosen 4 initial drugs for reformulation development in 2018. Three of these drugs are in the Cardiovascular sector, and one drug in the Schizophrenia area of medicine.
* Data was taken from CMS Prescribing Data set from 2015 for only Medicare Part D Population