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.
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.