US FDA releases details of observations on Alkem's Baddi PlantMoneycontrol • 6 days ago
The US FDA had conducted an inspection of the facility last month and had made ten procedural observations, including issues with cleanliness and the company's failure to keep written documents on quality control procedures.
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While most of the corporates have shown double digit value growth, unit growth remains a challenge for the Indian pharma market, according to analysts
After the US FDA inspection, Alkem Laboratories has received Form 483 with 10 observations for its Baddi plant.
Various drugs manufactured by listed players like Sun Pharmaceuticals, Alkem Laboratories, Cipla Ltd, Mankind Pharma, Lupin Ltda and Torrent Pharma are included in the list.
Sun Pharma is recalling 54,960 bottles of Mesalamine Extended-Release Capsules, an anti-inflammatory medicine used to treat a type of bowel disease known as ulcerative colitis
Motilal Oswal recommended Neutral rating on Alkem with a target price of Rs 5160 in its research report dated February 21, 2024.
The company had hired an external agency to investigate the matter
The company received total consideration of USD 7,960,000.