Breaking News

You are here » Indian-Commodity  :  Corporate  :  Alembic Pharma gets USFDA's nod for Alogliptin, Metformin Hydrochloride Tablets

14-Sep2018

Alembic Pharma gets USFDA's nod for Alogliptin, Metformin Hydrochloride Tablets

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), KAZANO Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg of Takeda Pharma USA. Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg are indicated as an adjunct to diet and exercise to improve giycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin and metformin is appropriate.

Alogliptin and Metformin Hydrochloride Tablets, 12.5 mg/500 mg and 12.5 mg/1000 mg has an estimated market size of $22.5 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 77 ANDA approvals (64 final approvals and 13 tentative approvals) from USFDA. 

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.


Related News

View all news

Gujarat Petrosynthese to invest surplus funds in mutual funds, bonds, securities, shares

Gujarat Petrosynthese has received an approval to invest surplus funds in mutual funds, bonds, securities, shares, inter corporate deposits etc. to optimize its returns. The Board of Directors of the Company......

Reliance's Retail Unit delivers record-breaking performance in revenue, profits during FY19

Reliance Industries' Retail Unit--Reliance Retail has delivered a record-breaking performance in revenue and profits growth for the year 2018-19. Segment Revenue for FY19 grew by 88.7% Y-o-Y to Rs 130,566......

Tata Sponge Iron reports 48% fall in Q4 consolidated net profit

Tata Sponge Iron has reported results for fourth quarter and year ended March 31, 2019.The company has reported a fall of 47.82% in its net profit at Rs 24.37 crore for the quarter under review as compared......

Top News

View all news

Bank of Baroda's board to consider issuance of equity shares of Rs 5,042 crore to Govt

Bank of Baroda's board is going to consider issuance of equity shares of Rs 5,042 crore to Government of India on a Preferential Basis. The meeting of the Board of Directors of the Bank is scheduled to......

Gujarat Petrosynthese to invest surplus funds in mutual funds, bonds, securities, shares

Gujarat Petrosynthese has received an approval to invest surplus funds in mutual funds, bonds, securities, shares, inter corporate deposits etc. to optimize its returns. The Board of Directors of the Company......

Reliance's Retail Unit delivers record-breaking performance in revenue, profits during FY19

Reliance Industries' Retail Unit--Reliance Retail has delivered a record-breaking performance in revenue and profits growth for the year 2018-19. Segment Revenue for FY19 grew by 88.7% Y-o-Y to Rs 130,566......