A generic drug contains the same chemical substance as a drug that was originally branded and protected by patents (now expired).
What happens when a patent expires on a branded drug?
A generic drug is a pharmaceutical that contains the same chemical substance as a drug that was originally branded and protected by patents, but once they expire, duplicates are often allowed for sale as so-called generics.
Some characteristics such as the manufacturing process, formulation, color, taste, and packaging may slightly differ, but given that the active pharmaceutical ingredient (API) is the same, the medical profile of generics is believed to be equivalent in performance to the original and therefore its route to market it much quicker.
In order to market them, manufacturers must still conduct studies to determine whether their version is bioequivalent to the original drug; specifically, that its active ingredient releases into the bloodstream at virtually the same speed and amount, but as the original was already proven safe, the testing is much quicker and requires a much smaller clinical study.
QUINTA-ANALYTICA’s bioanalytical department has vast experience in drug testing, and has developed and validated over 300 bioanalytical methods for APIs under GLP, GMP, and ICH/FDA and EMEA directives.
Get in touch with us today to discuss your testing needs.
19 December 2023
Happy new year 2024
As we bid farewell to 2023, it's time to express our deepest gratitude for the collaboration.
4 December 2023
Our new clinical unit in Ostrava comes to life
It's a great pleasure to announce that after two years of hard work, the brand-new clinical unit in Ostrava with 36-beds capacity has been opened.
3 October 2023
Meet us at the heart of Pharma, CPHI 2023
Quinta-Analytica is attending CPHI 2023 in Barcelona