Alkem Laboratories Slumps On U.S. Drug Regulator’s Observations
Alkem Labs sees biggest drop in a month on Ankleshwar plant worries.
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Alkem Laboratories Ltd. fell as much as 5.33 percent to Rs 1,586, after the company received three 483 observations from the U.S. Food and Drug Administration for its Ankleshwar plant.
The U.S. drug regulator conducted an inspection at the company’s active pharmaceutical ingredient manufacturing facility in Gujarat, from December 5 to December 9, Alkem said in its filing to the exchanges.
The company shall put together a detailed response with adequate corrective and preventive measures to address the U.S. FDA observations and the same is proposed to be filed within the timeline stipulated by U.S. FDA.Alkem Laboratories’ Exchange Filing
Form 483 lists observations that may constitute violations of FDA guidelines, according to the regulator’s website.
The Alkem management was planning to launch four new drugs in the second half of the financial year, according to Nomura’s report post the announcement of Alkem’s second quarter earnings. The U.S. regulator’s observations could delay some of the approvals.
Alkem’s U.S. sales grew by 17.9 percent year-on-year to Rs 574.3 crore in the first half of the current financial year, contributing 35.0 percent to the company’s consolidated revenues.
Previous Regulatory Run-Ins
In September, Alkem’s Daman plant had received thirteen 483 observations in the inspection report. The same plant received the U.S. regulator's clean-chit after a separate inquiry in October, specifically for bio-analytical studies performed for two abbreviated new drug applications.
Apart from Ankleshwar, Alkem has FDA approved active pharmaceutical ingredient manufacturing facilities in Mandva in Gujarat and California. Alkem’s manufacturing facilities in Daman, Baddi in Himachal Pradesh, and St Louis in Missouri also have the regulator’s approval.
