Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Sinequan Capsules 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of Pfizer Inc. (Pfizer).
Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg have an estimated market size of $ 41 million for twelve months ending December 2020. Alembic has a cumulative total of 141 ANDA approvals (124 final approvals and 17 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
