Alembic Pharma gains after USFDA final approval for antibiotic drug

Alembic Pharmaceuticals gained 1.49% to Rs 927 after the company said it received US drug regulator's final approval for Doxycycline Hyclate tablets in 75 mg and 150 mg strengths.

Alembic Pharmaceuticals on Wednesday (1 July) announced that it 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 Acticlate tablets of Almirall. The drug is is 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 $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.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. Its consolidated net profit jumped 54.8% to Rs 203.52 crore on a 30.2% rise in net sales to Rs 1,206.83 crore in Q4 March 2020 over Q4 March 2019.

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