Strides Arcolab Receives US FDA Approval For Its Italian Facility
DSIJ Intelligence / 18 Sep 2013
Strides Arcolab has said that it has received a facility approval from US FDA. This facility is based in Italy and has already seen approvals form other few regulators as well.
Strides Arcolab (Strides) has received an US FDA approval for its Beltapharm’s facility located at Milan, Italy. Beltapharm is a state-of-the-art manufacturing facility approved by EU and TGA (Australia). It is engaged in manufacturing of liquids, semi-solids, ointments and creams.
The company has also said that it is expecting its first approval of a niche semisolid product by Q1 2014. The facility is a part of Strides’ retained business as was acquired by the company in 2006.
Strides is developing a portfolio of liquids and semi-solids products to cater to US and EU markets and currently has over 12 products at various stages of development/approvals. Strides already has a presence in the sells semi-solids market in the UK.
Commenting on the event, Manish Gupta, CEO – Pharma said, “this approval provides further impetus to our Pharma business and marks our foray into the attractive but complex semi-solid market in US. Our first product, which is expected to be commercialized by Q1 2014, has undergone extensive clinical trials. The product will be marketed by one of the top 10 generic companies in US market ”.