Alembic Pharmaceuticals Limited announces USFDA Final Approval for Amlodipine and Atorvastatin Tablets USP

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) Amlodipine and Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Caduet Tablets, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, of Pharmacia and Upjohn Co. LLC.

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Refer label for a detailed indication.

Alembic has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 971.15 as compared to the previous close of Rs. 972.55. The total number of shares traded during the day was 13969 in over 752 trades.

The stock hit an intraday high of Rs. 983.35 and intraday low of 958.70. The net turnover during the day was Rs. 13518546.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA Amlodipine Atorvastatin Tablets