SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Aurobindo Pharma’s arm receives USFDA’s approval for Diclofenac Sodium Topical Solution USP

07 Feb 2023 Evaluate

Aurobindo Pharma’s step down subsidiary -- Aurolife Pharma LLC has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Diclofenac Sodium Topical Solution USP, 2% w/w, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Pennsaid Topical Solution, 2% w/w of Horizon Therapeutics Ireland DAC (Horizon). The product is expected to be launched in Q1FY24.

The approved product has an estimated market size of around $487 million for the twelve months ending December 2022, according to IQVIA. This is the first ANDA to be approved out of the Aurolife Unit-II, North Carolina, USA, used for manufacturing topical products. Aurobindo now has a total of 430 ANDA approvals (404 Final approvals and 26 tentative approvals) from USFDA.

Diclofenac Sodium Topical Solution USP, 2% w/w is Indicated for the treatment of the pain of osteoarthritis of the knee(s).

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

Aurobindo Pharma Share Price

1385.65 0.00 (0.00%)
17-Apr-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1675.20
Dr. Reddys Lab 1235.40
Cipla 1238.30
Zydus Lifesciences 942.55
Lupin 2324.25
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:

×