Strides Arcolab Limited has received US Food and Drug Administration (FDA) approval for its Beltapharm’s facility at Milan, Italy.
This state-of-the-art, EU and TGA (Australia) approved facility located in Milan, Italy, manufactures liquids, semi-solids, ointments and creams.
The company is expecting its first approval of a niche semisolid product by Q1 2014.
Commenting on the event, Manish Gupta, CEO – Pharma, Strides Arcolab 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.”
Strides is developing a portfolio of liquids and semi-solids products for the US and EU markets and currently has over 12 products at various stages of development/ approvals. Strides already sells semi-solids in the UK market.
Beltapharam S.p.A., Italy, a subsidiary of Strides Arcolab Limited (Strides) was acquired by Strides in the year 2006. The facility is part of the retained Pharma Business of Strides Arcolab and manufactures liquids, semi-solids, ointments and creams. The facility is approved by the regulatory authorities of US, EU and Australia. It is also approved by UNICEF and Clinton Foundation for supplies under their programme.