Glenmark Pharmaceuticals said that the United States’ Food and Drug Administration (FDA) has concluded inspection of its manufacturing facility in Monroe, North Carolina.
Glenmark Pharmaceuticals said that the United States’ Food and Drug Administration (FDA) has concluded inspection of its manufacturing facility in Monroe, North Carolina. In an exchange filing, the company stated that the authorities conducted a Good Manufacturing Practice inspection at the facility between June 9-17.
Outcome of Inspection
Glenmark said that the FDA has issued a Form 483 upon the conclusion of its inspection at the manufacturing facility. The federal agency reported five observations in its report; however, the company said that there was no observation on data integrity, and all five observations were procedural in nature.
Glenmark stated that it will work with the Food and Drug Administration to address the observations by the agency. Furthermore, the company will respond to the FDA within a stipulated timeline.
Glenmark gets DCGI approval for cancer medicine
Earlier on June 9, Glenmark Pharmaceuticals received approval from the Drugs Controller General of India (DCGI) for Zanubrutinib, an oncology medicine. The medicine developed by US-based pharmaceutical company, BeOne Medicines, will be marketed by Glenmark under the brand name BRUKINSA.
The cancer medicine launched by Glenmark is known for its high response rate and lower cardiac event rate. According to Glenmark, BRUKINSA has a 1.9 percent serious cardiac event rate against the industry average of 7.7 percent serious cardiac event rate.
Glenmark’s share price
In the past month, Glenmark Pharmaceuticals’ stock has gained 15.40 percent . On Wednesday, Glenmark’s share was up by 0.42 percent at Rs 1,660 per share, by 1 PM.
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