BioPhysics is focused on distributing topical, transdermal oral and transmucosal bases and certified active pharmaceutical ingredient(s),{APIs}, manufactured to our specifications in cGMP facilities with USP materials under cGMP controls for FDA registered 503a / 503b cGMP compounding facilities. Our bases and API’s answer the compliance requirements for compoent validation that is integral for all compounding  pharmacists.

Medical Need

Compounders answer the call for a significant unmet medical need that can be lifesaving for many patients. Most approved drugs are in pill form. Yet this method of delivery can be problematic for many patients. This is especially significant when:

1. Patients are young or elderly and can’t swallow pills;
2. The dosage of the pill is significantly greater than needed which can result in pill splitting;
3. The drug is not well tolerated by the patient’s gastro-intestinal system and it results in side effects;
4. The gastro-intestinal and the “first pass liver effect” destroys most of the active, orally delivered drug before it can pass into systemic circulation resulting in a sub therapeutic dose;
5. The patient’s condition is localized and better treated with a localized application of a pharmaceutical agent than a systemic delivery of that agent; and,
6. The shelf life of the active ingredient requires it to be produced at the time of prescription.

In working with doctors to customize specialty pharmaceuticals for the needs of their patients, 503a / 503b compounders can depend on BioPhysics’ bases and active ingredients to answer their demand for components that can be integrated into their cGMP manufacturing systems.