Alembic Pharma gets USFDA approval for testosterone gel

The drug major on Wednesday announced that its joint venture, Aleor Dermaceuticals (Aleor), has received US drug regulator's tentative approval for testosterone gel.

Alembic Pharma in an exchange filing said the tentatively approved ANDA is therapeutically equivalent to the reference listed drug product, AndroGel of AbbVie Inc. Testosterone gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

According to IQVIA, testosterone gel has an estimated market size of $107 million for twelve months ending September 2020. Alembic has a cumulative total of 136 ANDA approvals (117 final approvals and 19 tentative approvals) from the US Food & Drug Administration (USFDA).

Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies (Orbicular) formed in April 2016 focusing on commercialising dermatology products globally.

Shares of Alembic Pharma were down 1.54% at Rs 981. The scrip traded in the range of Rs 974.15 to Rs 1000 so far during the day.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

The drug maker reported a 35.4% jump in consolidated net profit to Rs 333.37 crore on 17.4% rise in net sales to Rs 1,457.10 crore in Q2 September 2020 over Q2 September 2019.

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