Alembic Pharma gets USFDA approval for 3 ANDAs

Alembic Pharmaceuticals Limited has received the US Food & Drug Administration (USFDA) approvals for 3 of its ANDAs. It has total of 107 ANDA approvals (95 final approvals and 12 tentative approvals) from the USFDA.

It has got final approval for Deferasirox tablets, 90 mg and 360 mg, which is equivalent to Jadenu Tablets, 90 mg and 360 mg, by Novartis Pharmaceuticals Corporation. According to IQVIA, the estimated market size is US$415 mn for 12 months ending December 2018.

It has also got final approval for Deferasirox tablets for Oral suspension 125 mg, 250 mg, and 500 mg, which is equivalent to Exjade Tablets for Oral suspension, 125 mg, 250 mg, and 500 mg, by Novartis. As per QVIA, the estimated market for this drug is US$135 mn for 12 months ending December 2018.

It has got tentative approval for Deferasirox tablets 180 mg, equivalent to Novartis' Jadenu Tablets, 180 mg. IQVIA has stated that the estimated market for this drug is US$59 mn for 12 months ending December 2018.

Deferasirox is used for the treatment of chronic iron overload due to blood transfusions in patients over 2 years of age.

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, is engaged in the manufacturing and marketing of generic pharmaceuticals products all over the world.

On Friday, the stock of Alembic opened at Rs. 551. During the day, it made intra-day high and low of Rs. 559.10 and Rs. 544.25,respectively. At 3:06 pm, the stock was trading at Rs. 548.75.