Dr. Rassman, generic finasteride is available in india manufactured by Cipla and other pharma companies. the name written in them are Finasteride tablets USP 1mg (eg: finpecia from cipla). A search in internet for USP returns “the United States Pharmacopeia (USP) is an official public standardsâ€“setting authority for all prescription and overâ€“theâ€“counter medicines and other health care products manufactured or sold in the United States.” Link: https://www.usp.org/aboutUSP/
so does that means these generics are approved by FDA or are they keeps the standards set by US law? thanks
There are some companies outside the US that make generic drugs that are marketed in the United States and they are legitimate. There is a difference between when the manufacturer meets FDA manufacturing guidelines and the company’s ability to sell the drug in the United States.
In the case of finasteride 1mg tablets, the restrictions are enforced through the laws that govern patent protection. If company ‘X’ decided that it wanted to sell a drug in the US that is covered by U.S. Patent, the patent owner can get a court to supply a cease and desist order to company ‘X’. The owner of the patent can also file for triple damages for lost revenues under existing patent laws.