Shares of pharma company Kopran rallied 10 percent intraday on June 18 after the US health regulator approved DMF of Atenolol filed by its subsidiary.
The company said the Active Pharmaceutical Ingredients manufacturing facility at Mahad of Kopran Research Laboratories, a 100 percent subsidiary of Kopran, was inspected by the US Food and Drug Administration (USFDA) in January 2019 without any observation under Para 483.
Then the company had filed the drug master file (DMF) of Atenolol which has now been approved by the USFDA.
"The company can commence supplies of the API Atenolol to the US market," Kopran said in its BSE filing.
Atenolol is used in the treatment for chest pain and high blood pressure.
The DMF is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder, said USFDA.
The stock was quoting at Rs 40.05, up Rs 2.90 or 7.81 percent on the BSE at 14:12 hours IST. So far it shot up 148 percent from its March lows.
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