Moneycontrol Bureau
Alkem Laboratories shares gained 2 percent intraday Friday after the company received establishment inspection report from the US health regulator for its Daman formulation facility.
With this report, the inspection has now been closed by the US Food & Drug Administration, the Mumbai-based pharma company said in its filing.
The USFDA had inspected Daman formulation facility from September 20-29 and had issued Form-483 with 13 observations.
Post this, the company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
Alkem Labs said the 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. This inspection was based on an ANDA filed by the company.
Recently the US FDA had conducted an inspection at the company's API (active pharmaceutical ingredient) manufacturing facility at Ankleshwar from December 5-9.
In this regard, the company had received the inspection report which contains three 483 observations. It had said the detailed response with adequate corrective and preventive measures to address the US FDA observations was proposed to be filed within the timeline stipulated by US FDA.
At 12:33 hours IST, the stock was quoting at Rs 1,628.00, up Rs 22.10, or 1.38 percent on the BSE.Posted by Sunil Shankar Matkar
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