USFDA inspecting IPCA Labs' Indore SEZ formulations facility: Exclusive
IPCA Labs’ facility in Indore SEZ, along with the facilities in Silvassa and Ratlam, have been under import alert since 2015.
The United States Food and Drug Administration (USFDA) has been inspecting IPCA Laboratories' formulations manufacturing facility at the Indore SEZ since last week, people with knowledge of the matter told CNBC-TV18.
The inspection at the Indore SEZ facility was likely to have started in the previous week.
IPCA Laboratories’ Indore SEZ plant manufactures formulations. The company has not revealed any details about the ongoing USFDA inspection at the aforementioned SEZ facility. Further, IPCA Labs’ facility in Indore SEZ, along with the facilities in Silvassa and Ratlam, have been under import alert since 2015.
The company’s active pharmaceutical ingredient (API) manufacturing facility in Ratlam, Madhya Pradesh, was under inspection from June 5 to June 13 and has been issued a total of 11 observations so far.
IPCA Labs’ Silvassa unit underwent an inspection by the US drug regulator back in April 2023 and was issued three observations during the inspection.
The market saw it in a positive light that the Silvassa and Ratlam facilities were inspected this year, as it instilled hope that a successful inspection will clear the way for the import alert to be lifted.
However, the market is cautious as IPCA Labs is believed to have data integrity issues, which led to the strongest action of all an Import Alert in 2015.
In the March quarter, IPCA Labs reported a net profit of Rs 76.52 crore, falling by 41.24 percent from Rs 130.23 crore posted in the same quarter last year, while its net sales gained 17.26 percent to Rs 1,511.6 crore compared to Rs 1,289.1 crore in the year-ago period.
Shares of IPCA Laboratories closed 0.58 percent lower at Rs 731 on Monday.
(Edited by : Rukmani Krishna)
First Published: Jun 19, 2023 4:30 PM IST
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