FDA spurns hay fever drug from India's Glenmark
In its attempt to be transparent about manufacturing machinery, Indian drugmaker Glenmark appears to have shot itself in the foot with the FDA. On Saturday, the Maharashtra-based company disclosed that its hay fever drug, Ryaltris, had been rejected by the US health regulator.
In its complete response letter, the FDA cited deficiencies in the Drug Master File (DMF) related to one of the active pharmaceutical ingredients and a manufacturing plant, Glenmark noted in a statement, adding that it is confident the issue can be resolved in the next 6 to 9 months.
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