Alembic Pharmaceuticals announces USFDA Final Approval for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Dilacor XR Extended-Release Capsules, 120 mg, 180 mg, and 240 mg, of Allergan Sales LLC (Allergan). Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. It is also indicated for the management of chronic stable angina. Refer label for a detailed indication.

Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg have an estimated market size of US$ 28.2 million for twelve months ending June 2024 according to IQVIA.

Alembic has a cumulative total of 217 ANDA approvals (190 final approvals and 27 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 1141.10 as compared to the previous close of Rs. 1159.75. The total number of shares traded during the day was 5787 in over 484 trades.

The stock hit an intraday high of Rs. 1186.00 and intraday low of 1137.00. The net turnover during the day was Rs. 6724133.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 FinalApproval USFDA ANDA DiltiazemHydrochloride ExtendedReleaseCapsules