In response to the Import Alert published on the US FDA website concerning certain products manufactured by Beltapharm SpA, Italy, Strides Arcolab (‘Strides’) has clarified that its Italian subsidiary Beltapharm has only one ANDA approved product namely Imiquimod Cream for the US market. This product has been recently launched and is freely available.
The products mentioned in the Import Alert webpage http://www.accessdata.fda.gov/cms_ia/importalert_190.html are manufactured by Beltapharm for an African customer for over fiveyears and the company is working with the US FDA and the African customer, on the circumstances on how these products reached the US market.
Strides further wishes to clarify that it has no role in the distribution of any of these products in the US territory.
EP News Bureau- Mumbai
- Advertisement -