Alembic Pharmaceuticals has received USFDA approval for its ANDA for Doxycycline Hyclate Capsules USP, 50 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vibramycin Capsules, 50 mg and 100 mg, of Pfizer Inc.
Doxycycline is indicated for a wide variety of bacterial infections including those caused by several gram-negative as well as gram-positive microorganisms.
Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, have an estimated market size of US$ 80 million for twelve months ending December 2017 according to IQVIA.
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