The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xylocaine Ointment, 5%, of AstraZeneca Pharmaceuticals LP (AstraZeneca). Lidocaine Ointment USP, 5% are indicated for production of anesthesia of accessible mucous membranes of the oropharynx. Lidocaine Ointment USP, 5%, has an estimated market size of $ 97 million for twelve months ending December 2017 according to IQVIA.
The company has a cumulative total of 79 ANDA approvals (66 final approvals and 13 tentative approvals) from USFDA, including this first ANDA approval for Aleor.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Bhupendra Singh Chundawat is a seasoned technology journalist with over 22 years of experience in the media industry. He specializes in covering the global technology landscape, with a deep focus on manufacturing trends and the geopolitical impact on tech companies. Currently serving as the Editor at Udaipur Kiran, his insights are shaped by decades of hands-on reporting and editorial leadership in the fast-evolving world of technology.