Shares of Glenmark Pharmaceuticals fell close to 7 percent to Rs 466.25 apiece, its lowest since 4 April 2013, in early trade on Monday.
According to the company's stock exchange filing, the US FDA (Food and Drug Administration of the United States) had issued a Complete Response Letter (CRL) for nasal spray Ryaltris and cited deficiencies in the Drug Master File with regard to one of the active pharmaceutical ingredients (API) and in its manufacturing facilities.
Further it said, "The CRL does not specify any deficiencies with the clinical data supporting the New Drug Application for Ryaltris. We feel confident that we should be able to resolve these issues within the next 6 to 9 months."
Glen Pharma said that it will continue to pursue the process of getting Ryaltris approved and work closely with the FDA on the same.
Moreover, on Monday, the pharma company announced that its Brazilian subsidiary, Glenmark Farmacêutica has entered into an exclusive partnership agreement with Novartis Biosciences S.A, a subsidiary of Novartis AG, for three respiratory products, that is to do with treatment of the symptoms of chronic obstructive pulmonary disease (COPD) in Brazil. This agreement will be effective from 1 July 2019.