Shasun Pharmaceuticals, a global pharmaceutical organization offering world class capabilities and facilities has successfully completed US FDA inspection during the first week of June 2013. The main focus of the inspection was for post approval of certain products which has been commercially launched recently by company’s customer in US. The company has informed that, on completion of the inspection, the US FDA authorities concluded that, the facility, systems and practices comply with US FDA requirements and there were no recommendations or observations.
The facility also underwent a Brazilian ANVISA (National Health Surveillance Agency) inspection in the first week of July 2013. This is a pre-approval inspection for an NDA product with a big pharmaceutical company associated with Shasun. The regulatory authorities concluded that the facility, systems and practices comply with ANVISA cGMP requirements.
Shasun Pharmaceuticals manufactures active pharmaceutical ingredients (APIs), their intermediates and enteric coating excipients with a significant presence in some key generics. Shasun has created a strong product portfolio, building on its R&D Expertise, regulatory capabilities and multi scale production capacities. It is one of the largest producers of Ibuprofen worldwide.
