Claris bags MHRA Approval

Ahmedabad-based Claris Life sciences Limited announced on Monday that their plant has been approved by the Medicines and Healthcare product Regulatory Agency (MHRA) of the United Kingdom. With this approval, the company, which already has received 137 approvals in Europe and another 93 registrations are awaiting approvals, can re-launch its bag products in EU.

Claris had recalled three of its products sold in bags from the US in June 2010 and has initiated corrective actions towards bagging the USFDA approval. Post this recall the MHRA had inspected the Claris plant in Ahmedabad between October 4 to 8 last year. The approval also gains significance as recently Claris had received approvals for its flagship product Propofol in the EU. The European Union with approximately 24% of the global injectable market is the second largest market in the world, second only to the United States.

 

Claris is one of the largest sterile injectables pharmaceutical companies in India with a market presence across 76 countries. It 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. Many of these products are generic drugs that are capable of being directly injected into the human body and are used in the treatment of critical illnesses.