Alembic Pharma gets Final USFDA nod for Doxycycline Hyclate Tablets

Vadodara: Alembic Pharmaceuticals Limited 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. It is also indicated for anthrax including inhalation anthrax. It is indicated as an alternative treatment for certain infections where Penicillin is contraindicated. It is also indicated as an adjunctive therapy for acute intestinal amebiasis and severe acne and for prophylaxis of malaria.

Doxycycline Hyclate Tablets USP, 75 mg and 150 mg have an estimated market size of US$ 17 million for twelve months ending March 2020 according to IQVIA.

Alembic now has a total of 125 ANDA approvals (111 final approvals and 14 tentative approvals) from USFDA. 

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Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company headquartered in Gujarat.

Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

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