Indoco Remedies Goa facility under warning letter gets USFDA relief - Shares rise

By CNBCTV18.com
May 3, 2023 3:28:21 PM IST (Published)

Shares of Indoco Remedies Ltd. jumped over 3 percent in trade on Wednesday after the company’s Goa plant 1 received an Establishment Inspection report with a Voluntary Action Indicated (VAI) status.

The plant, located in Verna, Goa is the company's solid dosages facility. With this EIR, the warning letter issued to the facility in 2019 now stands closed.

A surveillance inspection was held for Plant 1 between January 16, 2023, to January 20, 2023.

VAI is the second-best classification that a plant can get from the USFDA. The classification is issued by the regulator when objectionable conditions or practices are found during the inspection, but the agency is not prepared to take or recommend any administrative or regulatory action. Rather, the plant takes remedial actions and responds to the regulator’s observations.

On the other hand, OAI is the strictest regulatory classification wherein USFDA recommends administrative actions on the plant like slower approvals, quicker re-inspection, or even an import alert.

Indoco Remedies said that the change in compliance status for Plant 1 in Goa should pave the way for approvals of ANDAs (abbreviated new drug applications) submitted from this site.

Shares of Indoco Remedies are trading 2 percent higher at Rs 328.55. The shares are still trading 20.4 percent lower on a year-to-date basis.

(Edited by : Rukmani Krishna)