Granules India’s arm gets USFDA’s nod for Valganciclovir Hydrochloride for Oral Solution

05 Feb 2020 Evaluate

Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc., has received approval from US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) for Valganciclovir Hydrochloride for oral solution, 50 mg/mL. It is bioequivalent to the reference listed drug product (RLD), Valcyte for oral solution, 50 mg/mL, of Roche Palo Alto LLC. Valganciclovir Hydrochloride solution is an antiviral medication used to treat cytomegalovirus infections.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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