Alkem Laboratories sinks 3 percent on US FDA’s 10 observations for Himachal unit

After the US FDA inspection, Alkem Laboratories has received Form 483 with 10 observations for its Baddi plant.

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Alkem Laboratories shares fell 3 percent in the early trade on March 28 after the US Food and Drug Administration (FDA) issued a Form 483 with 10 observations for its manufacturing facility in Himachal Pradesh.

The US drug regulator had inspected the pharma company’s manufacturing facility in Baddi from March 19 to 27 after which it issued Form 483 with 10 observations. It was a good manufacturing practice (GMP) as well as a pre-approval inspection. There was no data integrity observation and the inspection was part of the routine business operations, the company said.

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At 9.20 am, shares Laboratories was quoting at Rs 4,857.95 on the NSE, lower by 2.9 percent from the previous session’s closing price.

As per the USFDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator observe conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

On February 26, the pharma player denied allegations of tax evasion. It was reported that the income tax department found that Alkem Laboratories allegedly made bogus and excessive deductions for its manufacturing units in Sikkim.

The purported value of such deductions is claimed to exceed Rs 1,000 crore. Numerous deductions were reportedly claimed under various special sections like 80-IC, according to sources within the firm.

Over the past six months, the stock has gained 40 percent against a 13 percent rise in the benchmark Nifty50.

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