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Granules India arm gets USFDA nod for generic version of Roche antiviral

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

Press Trust of India  |  New Delhi 

Pharma, medicine, drugs, Pharmaceuticals

Drug firm 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 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 were trading at Rs 153 a piece on BSE, up 4.83 per cent from the previous close.

First Published: Wed, February 05 2020. 10:32 IST
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