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Generix Biotech specializes in developing and manufacturing complex generic injectable products for oncology, endocrinology, hypertension, and cardiovascular treatments. Our expert team leverages cutting-edge technology to tackle challenging formulations, improving patient outcomes by providing vital medications.
We employ and highly focused approach, PS concentrating our resources on a select portfolio of generic medications.
Regulatory agencies across Mexico, Central America, and South America are prioritizing the review of generic comm drug applications, particulary for complex generics with FD limited market competiton. This shift, characterized by increased transparency and imporved efficiency, is creating a regulatory environment more conducive to the development and approval on innovative generic pharmaceuticals.
Generix Biotech is committed to expanding its market presence across Mexico, Central and South America by continuing to develop strategic partnerships to commercialize our internally developed products
Complex generics demand unwavering focus and dedication to overcome significant supply, manufacturing, and analytical challenges. While mid-to- large cap pharmaceutical companies often lack the resource allocation flexibility for these inticate projects, Generix Biotch has positioned ourselves to fill this crucial market gap.
Intelligent selection of high value generic Injectable opportunities
Focus on challenging generic Injectable products, with low or no competition
We carefully select our in country partners ensuring our long term goals align completly.
Work in conjunction with our partners in each country bringing vital medications to market and improving patient access to high quality, affordable treatments.
Product identification through economic and technical due diligence
Small batch manufacture and analytical testing
Early stage R&D to support bioequivalence
CGMP registration batches, stability studies, human BE study
Regulatory submission and
approval
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