Moneycontrol Bureau
Claris Lifesciences shares plunged more than 7 percent intraday Monday after its subsidiary received USFDA Form 483 with five observations.
"Wholly owned subsidiary Claris Injectables has received five 483s during the inspection on the plant 1 - Clarion 1," the Ahmedabad-headquartered pharma company in its filing on August 26.
The plant, which is situated at Charcharvadi in Vasna, was inspected for prior approval inspection (PAI) by the US Food and Drug Administration from August 16-26.
PAI inspections are part of a normal course of business to approve the under approval abbreviated new drug application (ANDA). Currently the company has 24 ANDAs under approval with a total addressable market size of around USD 2 billion.
Sources told CNBC-TV18 that US FDA observations for the Vasna unit are related to standard operating procedure and not related to data integrity.
Claris' Vasna facility, which had received establishment inspection report in May 2016, is company's main facility supplying to the US.
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.
"The ANDA approval has come for the same plant where the USFDA had recently completed their prior approval inspection," the healthcare company says. At 11:43 hours IST, the scrip of Claris Lifesciences was quoting at Rs 256.80, down Rs 14.95, or 5.50 percent on the BSE.Posted by Sunil Shankar Matkar
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