SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Alembic Pharmaceuticals gets USFDA’s tentative nod for Selexipag for Injection

12 Jul 2024 Evaluate

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Selexipag for Injection, 1,800 mcg/vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Uptravi for Injection, 1,800 mcg/vial, of Actelion Pharmaceuticals US, Inc. (Actelion). Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

Based on the most recent update to the FDA’s online paragraph IV database listings, Alembic is the sole first applicant to have filed its ANDA for Selexipag for Injection, 1,800 mcg/vial, containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Upon final approval of this ANDA by USFDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the U.S. 

Alembic has a cumulative total of 208 ANDA approvals (180 final approvals and 28 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.


Alembic Pharma Share Price

763.55 4.55 (0.60%)
21-Apr-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1665.25
Dr. Reddys Lab 1220.75
Cipla 1232.90
Zydus Lifesciences 928.85
Lupin 2311.75
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:

×