Alembic Pharmaceuticals Limited has received various US Food & Drug Administration (USFDA) (Tentative or Final) Product Approvals during the quarter ended 30th June, 2023.

The company received final approvals for:

* Bepotastine Besilate Ophthalmic Solution, 1.5% - Bepotastine besilate ophthalmic solution 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

* Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg - Nadolol tablets are indicated for the long-term management of patients with angina pectoris and for the treatment of hypertension, to lower blood pressure.

* Carboprost Tromethamine Injection USP, 250 mcg/mL SingleDose Vials - Carboprost tromethamine injection, USP 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.

* Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multiple-Dose Vials - Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis.

* The company also received tentative approval for Doxycycline Capsules, 40 mg - Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea.

Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.