US FDA issues 3 observations under Form 483 for IPCA’s Piparia Unit

IPCA Laboratories, on  April 27 informed the exchanges that the US Food and Drug Administration (USFDA) issued three observations under Form 483 for the company’s formulations manufacturing unit situated at Piparia, Silvassa. The observations were followed by the USFDA inspection at the site from April 18 to April 26, 2023. The company said that it will work closely with the drug administrator to resolve these issues at the earliest.

On April 24, IPCA Labs had announced acquisition of 33.38 percent stake in Unichem Laboratories with a total investment of Rs 1,034 crores at Rs 440 per share. The board approved open offer of up to 26 percent in Unichem Labs at Rs 440 per share aggregating to Rs 805 crores. Following the announcement, the company stated that it was seeing a status quo from the USFDA on its plants, with no developments. The company raising concerns on the same, said that both Unichem and IPCA have their own respective products and the deal was better than most of the deals in the last five years. "Looking for good compliance track record and spare capacity, will have to focus on margin improvement. We are also looking at EBITDA of Rs 300 crores in the next 2 years and can go to Rs 1,700-1,800 crores of turnover".

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