Glenmark is the top loser on the BSE since the opening bell. The stock hit a new today at Rs.466.65, going down almost 7%.
The company announced on Saturday that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application for Ryaltris Nasal Spray. The CRL cites deficiencies in the Drug Master File (DMF) pertaining to one of the active pharmaceutical ingredients (APIs) and in the manufacturing facilities.
The CRL does not specify any deficiencies with the clinical data supporting the New Drug Application for Ryaltris.
The company has said that it should be able to resolve these issues within the next 6 to 9 months and will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.
A Drug Master File (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. The information contained in the DMF may be used to support an Investigational New Drug Application , a New Drug Application, an Abbreviated New Drug Application, another DMF, an Export Application, or amendments and supplements to any of these.
This news itself was so disappointing that the market largely ignored the news of today 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 indicated towards treatment of the symptoms of chronic obstructive pulmonary disease (COPD) in Brazil. This agreement will be effective from July 01, 2019 onwards. Glenmark will be responsible for promoting, commercializing and distributing of these products in Brazil.