Strides Arcolab secures US FDA approval for manufacturing facility in Italy

Bangalore-based Strides Arcolab Ltd has received a nod from US Food and Drug Administration (US FDA) for its manufacturing facility at Milan, Italy, the company said in a stock market disclosure.

The facility which has also secured approval from European Union (EU) and TGA Australia is expecting its first approval for a niche semisolid product.

“This approval marks our foray into attractive but complex semi-solid markets in the US. Our first product, which is expected by Q1 2014, has undergone extensive clinical trials. It will be marketed by one of the top 10 generic companies in the US market,” Manish Gupta, CEO – Pharma, Strides Arcolab, said.

Currently, the company is developing a portfolio of liquid and semi-solid products for the US and EU markets. It has over 12 products at various stages of development and approvals.

This US FDA nod brings reprieve for the company which recently received a warning letter from the nodal drug administration body against the sterile manufacturing facility of Agila Specialities Pvt Ltd, its wholly owned subsidiary.

This could prove to be a dampener for the company as it in the last leg of the deal to sell Agila Specialties to US-based Mylan Inc for $1.6 billion. Mylan recently got the green signal from the Indian authorities to bring in money for the deal.

The current development comes amid the recent crackdown on Indian pharma companies by US FDA. Recently the US drug regulator issued an import alert against Ranbaxy’s Mohali facility, banning all drugs made in the unit from getting exported to the US, the largest drug market in the world.

(Edited by Joby Puthuparampil Johnson)

Leave Your Comment(s)