SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Aurobindo Pharma receives USFDA approval for Isosulfan Blue Injection

03 Feb 2016 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Isosulfan Blue Injection, 1% (50 mg/5 mL) single-dose vials. The product is expected to be launched in Q4 FY15-16. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) LymphazurinTM Injection, 1% of Covidien.

Isosulfan Blue Injection under Cardio Vascular therapeutic group, is used in a lymphography procedure. Isosulfan Blue Injection upon subcutaneous administration delineates the lymphatic vessels draining the region of injection. The approved product has an estimated market size of $ 57 million for the twelve months ending December 2015 according to IMS.

This is the 24 th 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 237 ANDA approvals (205 Final approvals including 10 from Aurolife Pharma LLC and 32 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:

×