Company was slapped with import alert as product reached American market
Drug firm Strides Arcolab have been slapped with import alert
New Delhi: Drug firm Strides Arcolab on Wednesday 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 US Food and Drug Administration (FDA) 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 five years and the company is working with the USFDA and the African customer, on the circumstances on how these products reached the United States market,” it added.
The company further wishes to clarify that it has no role in the distribution of any of these products in the United States territory, Strides Arcolab said. Beltapharm has only one Abbreviated New Drug Application (ANDA) appr-oved product namely Imiquimod cream for the United States market.
This product has been recently launched and is freely available, it added. Under the import alert, authorities can detain wit-hout physical examination of unapproved new drugs promoted in the US.
( Source : PTI )
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