Alembic Pharma JV Aleor Dermaceuticals gets USFDA nod for testosterone topical solution

Drug firm Alembic Pharmaceuticals on Wednesday said its joint venture firm Aleor Dermaceuticals has received final approval from the US health regulator for Testosterone Topical Solution, used for treating testosterone deficiency. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Axiron Topical Solution of Eli Lilly and Company.

Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation, Alembic Pharmaceuticals said in a regulatory filing.

Testosterone Topical Solution actuation is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.


Quoting IQVIA data, Alembic Pharma said Testosterone Topical Solution USP, 30 mg per pump actuation has an estimated market size of USD 21 million for twelve months ended March 2021.

Alembic Pharma has a cumulative total of 145 ANDA approvals (127 final approvals and 18 tentative approvals) from the USFDA.

Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular), focusing on commercialising dermatology products globally.