Claris Lifesciences Slumps Despite Drug Approval as Vasna Plant Receives Five 483s 

Claris Lifesciences Ltd. stock fell after one of its plants in Gujarat received five ‘form 483’ observations from the U.S. Food and Drug Administration.

Wholly owned subsidiary Claris Injectables Ltd.’s manufacturing facility at Charcharvadi, Vasna was inspected by the FDA between August 16 and 26, the company said in a press release on Friday. It is confident of replying to the concerns within 15 business days, with corrective and preventive actions, the company added.

Form 483 is used by the FDA to document and communicate concerns discovered during plant inspections. The inspection was classified as Prior Approval Inspection, which is part of a normal course of business to approve generic drugs, according to Claris.

Drug Approval

On Saturday, Claris received the abbreviated new drug application approval for launching generic version of Flumazenil injection in the U.S.

The estimated market size in the U.S. for Flumazenil injection, which is used to reverse anesthesia, is $4 million, the company said in a press release. 

The drug approval cheer was overshadowed by the regulatory concerns for the Vasna plant, and the Claris Lifesciences stock fell as much as 6.3 percent to Rs 254.55 as of 10 am.