Alembic gets US FDA nod to market diet-exercise equivalent pill, for diabetics

VADODARA (BARODA) | MUMBAI | RAJKOT – In a regulatory filing submitted on Tuesday, Vadodara headquartered and Amin family owned Alembic Pharma said of having got approval from US FDA (Food & Drugs Administration) to market diet and exercise equivalent pill for diabetic patients.

Alembic Pharmaceuticals Limited today announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg, the filing claimed.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), J\JES:~P,® Tablets, 6.25 mg, 12.5 mg and 25mg of Takeda Pharms USA. Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, the filing read.

Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg has an estimated market size of US$ 65.6 million (~ 481 crore ~ 4.81 billion Indian rupees) for twelve months ending December 2017 according to IQVIA, the filing said.

Alembic now has a total of 78 ANDA approvals (64 final approvals and ~4 tentative approvals) from USFDA, the filing read.


Somehow, investors & traders did not reciprocate positively to the announcement, as the share prices of company dipped immediately after the announcement of the company hit the announcement for new drug marketing approval from regulatory body.

During the trading session on Tuesday on the Indian Bourses, Alembic Pharma shares trailed choppy path, but ended in GREEN Zone on positive counters, with an upward spike.