Capabilities

At DifGen Pharmaceuticals, we excel in advanced drug delivery through innovative research, state-of-the-art infrastructure, and comprehensive manufacturing. Our global partnerships drive high-quality healthcare solutions and medical advancements.

Research & Development

Manufacturing

Contract Manufacturing Organization

Integrated innovation that delivers better healthcare

DifGen Global Research & Development is dedicated to advancing new medicines, devices, and combination products that offer significant therapeutic benefits to patients around the world.

By blending creativity with scientific rigor, our team of scientists, engineers, medical doctors, and project leaders employs extensive expertise across a wide array of technologies. Together, we drive innovation in biologics, biosimilars, small molecule medicines, generics, and over-the-counter therapies, striving to deliver groundbreaking solutions that address diverse medical needs.

DifGen R&D Philosophy and Capabilities

This holistic approach and unique structure brings fresh thinking, different perspectives, and broader knowledge into our research and development process. It encompasses our expertise in devices, formulations, and analytics.

These are combined with deep therapeutic understanding and outstanding clinical and non-clinical development skills. Together, this enables us to create new treatments that integrate with patients’ needs and ultimately help make lives better. DifGen is committed to ensuring patient safety, managing regulatory compliance, tracking safety data and fulfilling pharmacovigilance requirements for our medicines worldwide.

R&D Capabilities

DifGen Pharmaceuticas is committed to being first to market while ensuring quality and affordability. Our R&D team, consisting of over 100 world-class scientists, has a proven track record of translating early drug opportunities into clinically proven candidates. Our state-of-the-art facility supports both GLP and cGMP regulations, enabling the development of diverse dosage forms beyond traditional tablets and capsules, including drug-device combination products, long-acting injectables, transdermal patches, films, and nasal suspensions. With cutting-edge research capabilities and specialized labs for formulation and analytical method validation, we continue to lead pharmaceutical innovation.

We employ a range of advanced equipment to support our manufacturing processes. Our compression machines are equipped with D tooling, B tooling, bilayer, and MUPS capabilities. For controlled-release coatings, we use a Wurster coater, while Soft Gelatin Encapsulation is handled by specialized machines. Sterilization is managed by a Gansons autoclave, and rapid mixing and granulation are performed with an RMG granulator. The site also includes,

Indigenous ball mill for particle size reduction

Universal testing machine (UTM) for mechanical property evaluation

Microsphere machine for pilot-scale production (up to 500g)

Blister packaging and leak testing systems

Fedegari autoclave with counter-pressure technology for sterile processing of bags, vials, and PFS

Comprehensive stability chambers for testing in regular, semipermeable, and Zone IV conditions

Head space analyzer for quality control