April 01, 2026 04:51 pm (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
Fuel prices rise: Premium petrol, diesel hiked amid oil price surge
Wed, Apr 01 2026
Defence PSU boom! Garden Reach Shipbuilders & Engineers stock rockets 20%—what’s driving the surge?
Wed, Apr 01 2026
Dalal Street on fire: Sensex soars, Nifty rockets—here’s why!
Wed, Apr 01 2026
Layoff alert: Oracle cuts 30,000 jobs globally, 12,000 hit in India
Wed, Apr 01 2026
PwC India announces leadership transition in Deals Business
Tue, Mar 31 2026
DBS Bank India launches relationship-led banking for 'India’s globally mobile, emerging affluent'
Tue, Mar 31 2026
Major expansion ahead: Govt clears 29 proposals under ECMS
Tue, Mar 31 2026