Granules India gets USFDA nod for Valganciclovir HCL oral solution

USFDA has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc, for Valganciclovir hydrochloride for oral solution, 50 mg/ml

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Granules India arm gets USFDA nod for Valganciclovir hydrochloride oral solution

New Delhi: 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.

Also read: Granules India gets USFDA nod for Loratadine tablets

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 per cent from the previous close.

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