Alembic Pharmaceuticals announces its first product approval from its Formulation Division IV, Jarod Facility

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received PAS (Prior Approval Supplement) approval from the US Food & Drug Administration (USFDA) for its Supplemental Abbreviated New Drug Application (sANDA) Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.

The sANDA, submitted as "Prior Approval Supplement," provides for an alternate drug product manufacturing site - Alembic Pharmaceuticals Limited, Formulation Division IV, Jarod, Gujarat, India for previously approved ANDA from Panelav Facility (F-I). This is the first product approval from Jarod Facility which was inspected in Dec 2022.

The approved sANDA is therapeutically equivalent to the reference listed drug product (RLD), Lyrica Capsules, of Upjohn. Pregabalin Capsules are indicated for neuropathic pain, postherpetic neuralgia, and other indications. Refer to our label for full indication.

Pregabalin Capsules have an estimated market size of US$ 244 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 597.40 as compared to the previous close of Rs. 577.25. The total number of shares traded during the day was 16188 in over 1597 trades.

The stock hit an intraday high of Rs. 604.00 and intraday low of 576.05. The net turnover during the day was Rs. 9612981.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA sANDA PASApproval PregabalinCapsules