The US FDA, which had inspected Alkem's Ankaleshwar API Facility in December, had earlier issued a form 483 to the company with its observations. Alkem says that the FDA has now closed the inspection, following the corrective and preventive action plan (CAPA) that the company submitted to the regulator.
The US FDA, Alkem says, reviewed the CAPA and has found the steps outlined acceptable. Alkem Laboratories saw strong Q3 results, and analysts in their reports had noted that Alkem EBITDA was higher than estimated, with both domestic and US formulations performing well. Axis Direct had issued a BUY call on the stock in February, saying that Alkem has been outpacing domestic market growth in Pharma. The stock has been moderately bullish - share price of Alkem hit a new 52 week high in the past week.
Photo source: AlkemLabs