August 17, 2026 09:40 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
Mahindra launches BLAZO i-TRK: All details inside
Sun, Aug 16 2026
Reliance Industries, Rolls-Royce join hands to explore indigenous engine for India’s AMCA fighter
Sat, Aug 15 2026
BSNL’s Independence Day gift: Re 1 Recharge, 412-Day Plan and 500 Free TV Channels. Check now
Sat, Aug 15 2026
Emami’s big snack bet: ₹750 crore investment, new WeMe brand targets ₹1,000 crore in 3-5 years
Sat, Aug 15 2026
HCG Q1 results: Cancer care major posts 190% jump in adjusted profit, revenue rises 13%
Fri, Aug 14 2026
Big relief for Zee Entertainment: SAT allows warrants issue, dividend access despite SEBI ban
Fri, Aug 14 2026
Olectra Greentech Q1 shocker: Revenue soars 66%, profit barely moves; shares crash 4%
Fri, Aug 14 2026
Red Friday on Dalal Street: Sensex plunges 300 points, Nifty slides amid geopolitical tensions
Fri, Aug 14 2026
Tata Motors shares jump 6% after Q1 profit soars 83% to ₹2,560 crore
Thu, Aug 13 2026