SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Aurobindo Pharma receives USFDA approval for Polymyxin B for Injection

05 Apr 2016 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Polymyxin B for Injection USP, 500,000 units/vial. This product is expected to be launched in Q2 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Polymyxin B for Injection USP, 500,000 units/vial of Eurohealth International Sarl.

Polymyxin B for Injection is an Anti-Infective used in the treatment of infections of the urinary tract, meninges, bloodstream and eye caused by susceptible strains of Pseudomonas aeruginosa. According to IMS, the approved product has an estimated market size of $7.6 million for the twelve months ending February 2016.

This is the 31st ANDA (including two 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 252 ANDA approvals (216 Final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.



Aurobindo Pharma Share Price

1488.50 9.95 (0.67%)
08-May-2026 16:59 View Price Chart
Peers
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..

About MoneyWorks4Me

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.

Our Vision

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.

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

MoneyWorks4Me ensures this through:

×