Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP, 75 mg and 150 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Acticlate Tablets, 75 mg and 150 mg, of Almirall, LLC. Doxycycline Hyclate Tablets, 75 mg and 150 mg are indicated for the treatment of certain Rickettsial, sexually transmitted, respiratory tract, bacterial and ophthalmic infections.
Doxycycline Hyclate Tablets USP, 75 mg and 150 mg have an estimated market size of $17 million for twelve months ending March 2020. The company now has a total of 125 ANDA approvals (111 final approvals and 14 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
Company Name | CMP |
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Sun Pharma Inds. | 1504.25 |
Dr. Reddys Lab | 6263.70 |
Cipla | 1406.25 |
Zydus Lifesciences | 948.20 |
Lupin | 1615.85 |
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