Funding
Funding not disclosed
Founders
Product
Problem
The pharmaceutical industry faces challenges in providing affordable access to essential medicines, with a significant portion of the global population lacking access to necessary treatments. Developing and manufacturing high-quality generic sterile injectable drug products requires specialized expertise and robust supply chain partnerships.
Solution
GenerX is a pharmaceutical development company focused on increasing access to affordable generic sterile injectable medications. The company leverages its expertise in formulation, analytical development, and regulatory affairs to identify and advance drug product candidates. GenerX collaborates with world-class Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) for product development and manufacturing. The company also strategically expands its pipeline through licensing agreements and the acquisition of promising drug product candidates.
Target Audience
GenerX targets pharmaceutical companies, generic drug manufacturers, and healthcare systems seeking to expand their portfolio of affordable sterile injectable medications.
Features
- Expertise in sterile injectable drug product formulation, including complex generics and novel delivery systems.
- Comprehensive analytical development capabilities, including method development, optimization, validation, and transfer in accordance with ICH and FDA guidelines.
- Experience in developing analytical control strategies for potential genotoxic impurities and stability-indicating assays.
- Strategic partnerships with FDA-approved CMOs/CDMOs for efficient and high-quality manufacturing.
- Focus on Quality by Design (QbD) principles throughout the product development lifecycle.
- Pipeline expansion through licensing and acquisition of drug product candidates.
- Capabilities in regulatory affairs for navigating U.S. and global market approvals.