Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Glyxambi Tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer). Empagliflozin and Linagliptin Tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Linagliptin is appropriate.
Empagliflozin and Linagliptin Tablets, 10 mg/5 mg and 25 mg/5 mg have an estimated market size of $ 244 million for twelve months ending June 2020. Alembic now has a total of 130 ANDA approvals (113 final approvals and 17 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
| Company Name | CMP |
|---|---|
| Sun Pharma. Inds. | 1920.10 |
| Dr. Reddys Labs. | 1177.80 |
| Cipla | 1418.00 |
| Lupin | 2175.00 |
| Zydus Lifesciences | 1187.00 |
| View more.. | |
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