Mumbai, Aug 1: Claris Lifesciences Limited (Claris), one of the largest sterile injectables pharmaceutical companies today announced receiving approval for its plant at Ahmedabad from the Medicines and Healthcare product Regulatory Agency (MHRA) of the United Kingdom.
With this approval Claris can re-launch its PVC bag line products in the European Union and this approval is a big step towards resolving the Bag issue in totality, a company statement said.
Claris had earlier recalled three of its products sold in bags from the US in June 2010. Post this recall, the MHRA had inspected the Claris plant in Ahmedabad in October last year. This approval will benefit Claris as EU is a lucrative market both in terms of revenue and margins.
The European Union is the second largest market for injectibles in the world, next only to the United States, the release said.
Recently, Claris had received approvals for its flagship product Propofol in the EU. The company has already received 137 approvals in Europe, while another 93 registrations are awaiting approvals.
Claris, which has a market presence in 76 countries is working with consultants towards resolving the USFDA issue and corrective actions are on track and the company is confident of inviting the regulator for a re-audit and resolving the issue soon, it said.
MHRA is one of the premier regulatory bodies in the world for pharmaceutical products and an approval of the manufacturing facility and Bag line from them can be considered to be a huge milestone toward resolving the US-FDA issue.
The company manufactures and markets products across various therapeutic segments including anaesthesia, plasma volume expanders, blood products, parenteral and enteral nutrition, infusion therapy, anti-infective, renal care, and oncology. A majority of these products are generic drugs that are capable of being directly injected into the human body. PTI