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Drug firm Strides Arcolab today said it has received the US health regulator’s approval for the Milan-based facility of its Italian subsidiary Beltapharm SpA.
The company has received approval from the US Food and Drug Administration (USFDA) for Beltapharm’s facility at Milan that manufactures liquids, semi-solids, ointments and creams, Strides Arcolab said in a statement.
“This approval provides further impetus to our pharma business and marks our foray into the attractive but complex semi-solid market in the US,” Strides Arcolab CEO (Pharma) Manish Gupta said.
He added that the company is expecting its first approval of a niche semi-solid product by the first quarter of 2014.
“Our first product, which is expected to be commercialised by Q1 2014, has undergone extensive clinical trials. The product will be marketed by one of the top 10 generic companies in the US market,” Gupta said.
Strides, which is developing a portfolio of liquids and semi-liquids for the US and EU markets, has over 12 products at various stages of development. It already sells semi-solids in the UK market.
The Bangalore-based firm had acquired Beltapharm SpA in 2006.
Shares of the company closed at Rs 878.65 apiece, up 3.74 per cent from the previous close on the BSE.
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