Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Valganciclovir Tablets USP, 450 mg. This product is to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Valcyte of Hoffman-La Roche Inc.
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 product has an estimated market size of $ 391 million for the twelve months ending February 2016 according to IMS.
This is the 69th ANDA (including 15 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 251 ANDA approvals (215 Final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1847.30 |
| Dr. Reddys Lab | 1293.25 |
| Cipla | 1347.70 |
| Zydus Lifesciences | 938.90 |
| Lupin | 2377.90 |
| View more.. | |
MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.
To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.
MoneyWorks4Me ensures this through: