MHRA Approves New Claris Lifesciences Plant In India
By Lori Clapper
Sterile injectables company, Claris Lifesciences, announced last week that the MHRA approved its second manufacturing plant located in Ahmedabad, India. The company says the addition of a second facility will help improve its capacities and expand its presence in regulated markets, particularly the European Union (EU).
Claris plans to install a line to manufacture lyophilized products in the new plant, which should be ready for commercial manufacturing at the end of 2014. The existing line manufactures aseptic sterilized products.
As the company is currently “functioning at high capacity,” it said the addition of its second plant is intended to provide necessary services to meet future needs, take steps toward sustainable growth, and to attain required regulatory approvals. The company has a large product pipeline, containing candidates that are either waiting for approval or are currently under development.
As of June 30, Claris has 13 abbreviated new drug applications (ANDAs) filed in the U.S., along with 14 molecules in Europe and 11 molecules in other regulated markets either awaiting approval or under development. In fact, the drug maker experienced 30 percent growth last quarter, according to a company announcement.
"This is the first regulatory inspection and compliance approval conducted by MHRA-UK in line with the EU GMP regulations for plant 2," Claris Lifesciences said in a filing on BSE. This approval covers the products in glass ampoules manufactured in several of the plant’s lines, the Business Standard reported.
Claris Lifesciences is one of the largest sterile injectables pharmaceutical companies in India manufacturing and marketing various therapeutic products, including anesthesia, plasma volume expanders, blood products, parental and enternal nutrition, infusion therapy, anti-infective, and renal care.