Alembic Pharmaceuticals as received various US Food & Drug Administration (USFDA) (Tentative or Final) Product Approvals during the quarter ended 30 June 2023 as detailed below:

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

Tentative approval - 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.

Final approval - 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.

Final approval - 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.

Final approval - 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.