USFDA approves Valganciclovir Hydrochloride of Granules India

Granules India on Wednesday said that Granules Pharmaceuticals, a wholly-owned foreign subsidiary of Granules India Limited, has received an approval from US Food & Drug Administration (USFDA) for Oral Solution 50 mg/ml of Valganciclovir Hydrochloride, which is bioequivalent to Reference Listed Drug (RLD) Valcyte for Oral Solution 50 mg/ml of Roche Palo Alto LLC.

Valganciclovir Hydrochloride solution is an antiviral medication used to treat Cytomegalovirus (CMV) infections in those patients who have HIV/AIDS or following organ transplant.

CMV is a common virus and can easily spread from one person to the other through body fluids like blood, saliva, urine, tears etc and there is no cure for the virus. It is related to the viruses that cause chickenpox, herpes simplex and mononucleosis and may cycle through periods when it’s dormant and then reactivates.

Meanwhile, in December 2019, USFDA had approved the ANDA filed by Granules India for Loratadine tablets USP, 10 mg (OTC). The approved ANDA is bioequivalent to the RLD Claritin tablets 10 mg by Bayer HealthCare LLC.

On Wednesday, the stock of Granules India jumped 5.9 per cent to Rs 154.50 from its previous close of Rs 145.95 on BSE.