Claris Lifesciences Receives MHRA Approval For New Plant

Claris Lifesciences announced before market hours today that it received the MHRA approval for its newly commissioned plant (plant 2) in Ahmedabad. This will help in enhancing capacities to grow in the regulated markets, especially the European Union. The company's specialty injectables business received the compliance approval conducted by MHRA-UK in-line with the EU GMP regulations for the new plant. This approval is for the terminally sterilized products presented in glass ampoules manufactured in Line 1 of the plant.

This is the first regulatory inspection under the approval and the products are currently under development, the company said in a statement. The company plans to install another line in this new plant which will be ready for commercial production by end of this year

As on first half of CY14, the company has approvals of 13 ANDAs in US, 14 molecules in the Europe and 11 molecules in other regulated markets (ORM). Additionally, there are 28 ANDAs in the US, 8 molecules in Europe and 10 molecules in ORM, which are filed and awaiting approval, said the company. To sustainably grow, attaining the required regulatory approvals is one of the key growth drivers; and the company has a large pipeline of products.

Claris Lifesciences is one of the largest sterile injectables pharmaceutical companies in India. The company manufactures and markets products across various therapeutic segments including anesthesia, plasma volume expanders, blood products, parental & enternal nutrition, infusion therapy, anti-infective and renal care.

After the announcement, the stock surged to 6.3% in the morning trade, now its trading up by 3.9%.