Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Linezolid Injection, 600 mg/300 mL (2 mg/mL). The product is expected to be launched by Q2 FY2016-17. The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zyvox Injection, 600 mg/300 mL (2 mg/mL), of Pharmacia & Upjohn Company (Pharmacia).
Linezolid Injection is an anti-infective used to treat infections caused by susceptible Gram-positive bacteria in some specific conditions. The approved product has an estimated market size of $ 87 million for the twelve months ending June 2016 according to IMS.
This is the 36th ANDA (including 2 tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 275 ANDA approvals (235 Final approvals including 13 from Aurolife Pharma LLC and 40 tentative approvals) from USFDA.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1872.40 |
| Dr. Reddys Lab | 1282.15 |
| Cipla | 1304.70 |
| Zydus Lifesciences | 956.65 |
| Lupin | 2249.70 |
| 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: