Alkem Labs slides nearly 3% after USFDA raises 10 objections for its Baddi plant

Alkem Labs Share Price: Alkem Labs slipped nearly three per cent on BSE on Thursday (March 28, 2024) after the USFDA raised 10 objections for the pharma company's manufacturing facility at Baddi, Himachal Pradesh, and issued Form 483.

The pharma stock closed at Rs 4999.00 on Wednesday and started the session on Thursday at Rs 4889.60.

The stock slipped to the Thursday's low of Rs 4849.30, a 2.99 per cent fall from the previous closing price.

Alkem Labs' stock was trading down by 2.85 per cent, or Rs 142.25, at Rs 4,856.75, at 10:51 am on Thursday.  

What is USFDA's objection?  

The USFDA had conducted an inspection at Alkem Labs' manufacturing facility at Baddi, Himachal Pradesh, from March 19, 2024 to March 27, 2024.

At the end of the inspection, the company has received Form 483 with 10 observations.

"This was a GMP as well as a pre-approval inspection. There is no data integrity observation. This Inspection is part of the routine business operations and the Company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations," Alkem Labs said in a statement on Wednesday.