Glenmark said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps
Glenmark Pharmaceuticals plunged over 6 percent intraday on June 24, after the pharma player said the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the new drug application for Ryaltris.
The CRL cites deficiencies in the Drug Master File pertaining to one of the active pharmaceutical ingredients and in manufacturing facilities, the company said in a regulatory filing.
At 1000 am, Glenmark was trading 6 percent down at Rs 469. The stock hit a fresh 52-week low at Rs 467.70 on the BSE.
“We would like to inform you that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray,” Glenmark Pharmaceuticals 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 six to nine months,” it added.
The company said it will continue to pursue regulatory approval for Ryaltris and work closely with the FDA to determine the appropriate next steps.
In a separate report, Glenmark said that it plans to partner with Novartis to promote, commercialize and distribute three respiratory products in Brazil. Novartis will be responsible for manufacturing the products and Glenmark will exclusively commercialise them in Brazil.
“A delay in Ryaltris approval (due to CRL issued by USFDA) will weigh on the stock until clarity emerges. The exclusive partnership arrangement will strengthen Glenmark’s respiratory franchise in Brazil,” said a Sharekhan note.