US FDA conducts inspection at Ipca facility; issues Form 483 with 3 observations

US FDA conducts inspection at Ipca facility; issues Form 483 with 3 observations

The company said it will submit its comprehensive response on these observations to the US FDA within the stipulated time.

FPJ Web DeskUpdated: Thursday, April 27, 2023, 10:36 AM IST
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US FDA conducts inspection at Ipca facility; issues Form 483 with 3 observations | ipca.com

The US FDA conducted an inspection at Ipca's formulations manufacturing unit at Piparia (Silvassa) from April 18 to April 26, the company announced through an exchange filing. At the end of the inspection the US FDA issued a Form 483 with three observations.

The company in the exchange filing said it 'will submit its comprehensive response on these observations to the US FDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest'.

Ipca to acquire Unichem

Ipca on April 24 announced that it will acquire 33.38 per cent shares in Unichem for Rs 1,034.06 crore. But after this announcement the shares of the company hit its 52-week low on April 26 as the deal was considered to be overvalued. The investors were not happy with this decision as Unichem reported flat revenues in the last four years and it also has a plain-vanilla generics portfolio.

Ipca shares

The shares of Ipca Laboratories continued its dive on Thursday as the shares fell to Rs 696.45, down by 0.73 per cent.

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