Hot Pursuit     03-Jul-23
Alembic Pharm gets US FDA approvals for five products in Q1 FY24
Alembic Pharmaceuticals said that it has received various product approvals (tentative or final) from the US Food & Drug Administration (US FDA) during the quarter ended 30 June 2023.

The company has received final approval for Bepotastine Besilate Ophthalmic Solution, an antihistamine indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. The approved product is therapeutically equivalent to the reference listed drug product Bepreve Ophthalmic Solution of Bausch & Lomb Incorporated.

The pharmaceutical company has received tentative approval for Doxycycline Capsules, which are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. The approved product is therapeutically equivalent to the reference listed drug product Oracea Capsules of Galderma Laboratories, L.P.

The company has received final approval for Nadolol Tablets. They are indicated for the long-term management of patients with angina pectoris and for the treatment of hypertension, to lower blood pressure. The approved product is therapeutically equivalent to the reference listed drug product Corgard Tablets of USWM, LLC.

The drug maker has received final approval for Carboprost Tromethamine Injection, a sterile solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation. It is also indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. The approved product is therapeutically equivalent to the reference listed drug product Hemabate Injection of Pfizer, Inc.

The drug maker has received final approval for Doxercalciferol Injection, which is indicated for treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. The approved product is therapeutically equivalent to the reference listed drug product Hectorol Injection of Genzyme Corporation.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. The company manufactures and markets generic pharmaceutical products all over the world.

The company reported net profit of Rs 152.60 crore in Q4 FY23, steeply higher from Rs 21.92 crore in Q4 FY22. Revenue from operations declined marginally to Rs 1406.45 crore in quarter ended 31 march 2023 from Rs 1415.74 crore in same quarter last year.

The scrip rose 0.75% to currently trade at Rs 641 on the BSE.

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