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Caplin receives USFDA’s voluntary action indicated status; shares down

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Caplin Steriles Ltd., a subsidiary of Caplin Point Laboratories Ltd., has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable and ophthalmic manufacturing unit near Chennai.

The inspection took place from May 22nd to May 31st, and the inspection classification by the agency was determined as Voluntary Action Indicated (VAI).

Also Read | Caplin Point to set up step-down subsidiary to focus on US market

C.C. Paarthipan, Chairman of Caplin Point Labs, said, “This is the fourth US FDA audit at this site and we’re pleased to receive the EIR with a satisfactory outcome. Our commitment to maintaining the highest levels of compliance at all our units remains steadfast. The receipt of the EIR will help in receiving continued ANDA approvals for this unit, which is an important growth engine for us”. 

Shares were down by 1.95 per cent to Rs. 1074 at 12.10 p.m. on the BSE.





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