Princeton-based Kenox Pharmaceuticals Inc. has announced that it is now fully prepared for clinical manufacturing of orally inhaled and nasal drug products (OINDPs). The company, which operates as a contract development and manufacturing organization (CDMO), has also expanded its GMP analytical testing capabilities to include in vitro bioequivalence (IVBE) testing. This expansion aims to support companies developing new nasal and inhaled therapies.
“Achieving clinical manufacturing readiness is a major milestone for Kenox,” said Sitaram Velaga, founder, president, and CEO of Kenox. “Our goal has always been to help partners reach the clinic faster and with greater confidence. By integrating development, GMP testing—including IVBE—and clinical manufacturing under one roof, we are significantly de-risking early-stage programs while delivering the speed, flexibility, and quality that innovative OINDP products demand.”
Kenox provides small-scale fill–finish operations for small molecules, peptides, and biologics. These operations offer batch sizes suitable for Phase I and Phase II clinical trials.
The company’s expertise covers nebulizers, soft mist inhalers (SMIs), nasal sprays, and dry powder inhalers (DPIs). It offers analytical and formulation development services along with performance testing for OINDPs, IVBE studies, and regulatory support packages. According to Kenox, these combined services are designed to reduce risk during development stages and shorten timelines by offering an integrated solution from feasibility through clinical supply.
Kenox says its expanded services will support programs in several therapeutic areas such as central nervous system disorders using nose-to-brain delivery methods—covering conditions like psychiatric illnesses, Alzheimer’s disease, ALS, Parkinson’s disease—as well as pulmonary diseases including asthma and COPD. The company is open to partnership discussions aimed at accelerating timeframes for bringing new therapies to clinic or market.
