Alkem Laboratories receives EIR from the USFDA

Alkem Laboratories has received establishment inspection report from the US health regulator for its Daman formulation facility. The US Food & Drug Administration (USFDA) had inspected Daman formulation facility from September 20-29 and had issued Form-483 with 13 observations. Meanwhile, it has closed inspection.

Alkem Laboratories had submitted a detailed Corrective and Preventive Action (CAPA) plan to the regulator within the stipulated timelines. USFDA has reviewed the CAPA and has found them acceptable. The USFDA had also conducted a bio-analytical inspection at Daman facility from October 24-28, which was cleared successfully without any 483 observations.

On the financial front, Alkem Laboratories' revenue  has increased by 18.55 per cent to Rs 1638 crore in Q2FY17 as compared to same period in previous financial year. The company’s operating profit too has risen by 21.54 per cent to Rs 311 crore in Q2FY17 on a yearly basis. Its net profit also has increased by 5.96 per cent to Rs 283 crore in Q2FY17 as compared to same period in previous financial year.

The stock price of Alkem Laboratories has increased by 1.96 per cent on bourses in early trades; and is trading at Rs 1623 on an intraday basis.