Pherros Biosciences produces a wide array of affordable generic pharmaceuticals through innovative processes that enhance accessibility of the global population to life-saving medicines.
From small batches to large scale commercial production, our facilities produce medicines to
meet marketplace demands and to stabilize supply. Our team of scientists and engineers are
expert in the development and formulation of all forms of pharmaceuticals.
Pherros Biosciences’ portfolio of generic medicines includes solid dose, sterile liquid, and
topical pharmaceuticals, amongst others; all of which are produced in state-of-the-art
facilities under rigorous standards that are continuously subjected to quality assurance
oversight, technological advancement, process monitoring and continuous improvement.
Pherros Biosciences’ generic pharmaceutical program identifies candidates for production based upon a number of factors including the needs of and accessibility by the community to vital medicines. In the United States, the pathways to approval through the FDA include abbreviated new drug applications (ANDA) and drugs approved under section 505(b)(2) that are based, in part, on the safety and effectiveness of already approved pharmaceuticals. These pathways are significant to our generic pharmaceutical program because they enable Pherros Biosciences to bring high quality, safe and effective pharmaceuticals to market at a fraction of the cost of non-generic pharmaceuticals. It is reported that generic pharmaceuticals save healthcare providers, consumers and governments billions of dollars per year.
During the approval process, candidates in Pherros Biosciences’ generic pharmaceutical program
are demonstrated to the FDA and other regulators to be the same as branded analogs with respect
to critical criteria such as active ingredient, dosage form, strength, route of administration
and intended use. Through research and analytics, generic pharmaceutical candidates are
submitted for approval on our own ANDA “applications” to the FDA with proof that the active
ingredient is the same as the active ingredient in the branded or reference listed drug (RLD),
information to show that the candidate is bioequivalent to the RLD and information showing that
the route of administration, dosage form, and strength are the same as those for the RLD
(amongst other information and material that make up our submissions).
Pherros Biosciences is proud to address the needs of community through generic pharmaceuticals
that are safe, effective and low cost. This allows us to meet our goals of increasing the
accessibility of the global population to life-saving medicines.