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Granules India arm gets USFDA nod for Valganciclovir hydrochloride oral solution

"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.

February 05, 2020 / 10:39 AM IST
 
 
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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 Rs 153 a piece on BSE, up 4.83 percent from the previous close.
PTI
first published: Feb 5, 2020 10:35 am

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