December 18, 2025 10:44 am (IST)
Follow us:
Two Aurobindo Pharma products receive USFDA approval
Hyderabad/Mumbai, Apr 1 (IBNS) Aurobindo Pharma Limited announced on Friday that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Valganciclovir Tablets USP, 450 mg; and Vancomycin Hydrochloride for Injection USP, 500 mg/vial and 1 g/vial.
The company said that the Valganciclovir Tablet is to be launched in Q1 FY16-17 and the Vancomycin Hydrochloride for Injection in the later part of the same fiscal year.
Valganciclovir tablets is an anti-viral used in the treatment of Cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome and prevention of CMV disease in kidney, heart or kidney-pancreas transplant patients.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Valcyte of Hoffman-La Roche Inc.
The approved product has an estimated market size of US$ 391 million for the12 months ending February 2016 according to IMS.
Vancomycin Hydrochloride for Injection is an antibiotic used in the treatment of severe infections caused by susceptible strains of methicillin-resistant (Beta-lactam resistant) staphylococci and others. The approved product has an estimated market size of US$ 94 million for the twelve months ending January 2016 according
to IMS.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Vancomycin® Hydrochloride for Injection USP, 500 mg/vial and 1 g/vial, of Fresenius Kabi USA, LLC.
Support Our Journalism
We cannot do without you.. your contribution supports unbiased journalism
IBNS is not driven by any ism- not wokeism, not racism, not skewed secularism, not hyper right-wing or left liberal ideals, nor by any hardline religious beliefs or hyper nationalism. We want to serve you good old objective news, as they are. We do not judge or preach. We let people decide for themselves. We only try to present factual and well-sourced news.
Support objective journalism for a small contribution.
Latest Headlines
SBI rolls out YONO 2.0! Banking gets a major digital upgrade
Wed, Dec 17 2025
Nephrocare IPO pops on debut, dialysis major lists at 7% premium
Wed, Dec 17 2025
Rupee hits new lifetime low, but top economist says ‘don’t panic’
Wed, Dec 17 2025
How AI will reshape India: TCS and CII drop their report
Tue, Dec 16 2025
Why Gold Loans Are a Better Option than Selling Your Gold?
Tue, Dec 16 2025