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The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Axiron Topical Solution, 30 mg per pump actuation, of Eli Lilly and Company.
Testosterone topical solution USP, 30 mg per pump actuation is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypoqonadisrn (congenital or acquired).
According to IQVIA, testosterone topical solution USP, 30 mg per pump actuation has an estimated market size of $21 million for twelve months ending March 2021.
Alembic has a cumulative total of 145 ANDA approvals (127 final approvals and 18 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company's consolidated net profit jumped 12% to Rs 251 crore on 6% increase in net sales to Rs 1,280 crore in Q4 FY21 over Q4 FY20.
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