Granules India gets USFDA nod for Valganciclovir hydrochloride oral solution

PTI New Delhi | Updated on February 05, 2020 Published on February 05, 2020

Drug firm Granules India Ltd on Wednesday said its foreign arm has received approval from the US health regulator for Valganciclovir hydrochloride oral solution, an antiviral medication.

“The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc, a-wholly owned foreign subsidiary of Granules India Ltd for Valganciclovir hydrochloride for oral solution, 50 mg/ml,” the company said in a regulatory filing.

It is bioequivalent to the reference listed drug product (RLD) -- Valcyte for oral solution, 50 mg/m, of Roche Palo Alto LLC, the filing said.

Valganciclovir hydrochloride solution is an antiviral medication used to treat cytomegalovirus infections.

Shares of Granules India were trading at ₹153 a piece on BSE, up 4.83 per cent from the previous close.

Published on February 05, 2020
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