Strides Arcolab working with USFDA on import alert on unit's products

NEW DELHI: Drug firm Strides Arcolab today said it is working with the US health regulator to ascertain how medicines not meant for the American market reached the country after it was slapped with import alert on products made at the plant of its Italian arm.

An import alert was issued by USFDA on its website concerning certain products manufactured by the company's subsidiary Beltapharm SpA, Italy, Strides Arcolab said.

"The products mentioned in the Import Alert webpage ... are manufactured by Beltapharm for an African customer for over 5 years and the company is working with the USFDA and the African customer, on the circumstances on how these products reached the US market," it added.

The company further wishes to clarify that it has no role in the distribution of any of these products in the US territory, Strides Arcolab said.

Beltapharm has only one Abbreviated New Drug Application ( ANDA) approved product namely Imiquimod cream for the US market. This product has been recently launched and is freely available, it added.

Under the import alert authorities can detain without physical examination of unapproved new drugs promoted in the US.