Claris Injectables Ltd (CIL), a wholly-owned subsidiary of the Ahmedabad-based Claris Lifesciences Ltd, has received five 483s from the US Food & Drug Administration for the plant 1 (Clarion 1) of its manufacturing facility at Charcharvadi, Vasna (Ahmedabad, Gujarat).
The company received 483s after US FDA’s inspection, classified as prior approval inspection (PAI), which was conducted from August 16 to August 26, 2016.
A Form 483 is issued by US FDA for violations of current good manufacturing practices which if unaddressed can lead to a warning letter or import alert by the regulator.
According to the company, PAI inspections are part of a normal course of business to approve the under approval ANDAs. Claris currently has 24 ANDAs under approval with a total addressable market size of the under approval products estimated to be around $ 2 billion.
CIL, which focuses on specialty injectables, manufactures products across multiple delivery systems, markets and therapeutic segments including anaesthesia, blood products, anti-infectives and plasma volume expanders.
Meanwhile, Claris Lifesciences, on August 27, has received an ANDA approval for Flumazenil injection USP, 0.5mg/5ml and 1mg/10ml, multiple dose vials, in the US. The estimated market size of this drug in the US is USD 4 million.
With this approval, the company now has a total of 16 approvals and 23 under approvals ANDAs.