Exemed Pharmaceutical Gets CDSCO Panel Nod To Manufacture Market Antidiabetic FDC
New Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed dose combination (FDC) of the antidiabetic drug Empagliflozin plus Sitagliptin Phosphate Monohydrate plus Metformin HCL ER (10 mg + 100 mg + 1000 mg/25 mg + 100 mg + 1000 mg).
This came after Exemed Pharmaceutical presented the proposal along with the Phase III clinical trial report before the committee.
The committee noted that the firm conducted a proposed Phase III clinical trial in two strengths, i.e.Empagliflozin + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin HCl IP (ER) (10mg+100mg+1000mg/ 25mg+100mg+1000mg) tablet.
Empagliflozin is used to treat type 2 diabetes. It works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Empagliflozin does not help patients who have insulin-dependent or type 1 diabetes.
Sitagliptin is an oral anti-diabetic medication used to treat type 2 diabetes. It's part of the gliptin class of drugs and is sold under the brand name Januvia, among others. Sitagliptin helps control blood sugar by: Stimulating the pancreas to release more insulin Signaling the liver to stop producing sugar when blood sugar is high; increasing the amount of circulating incretins The usual adult dose is 100 mg once a day.
Metformin is used alone or with other medications, including insulin, to treat type 2 diabetes (a condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Metformin is in a class of drugs called biguanides.
At the recent SEC meeting for endocrinology and metabolism held on February 20, 2025, the expert panel reviewed the proposal along with the Phase III clinical trial report before the committee.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the proposed FDC in the two strengths, i.e.Empagliflozin + Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin + Metformin HCl IP (ER) (10mg+100mg+1000mg/ 25mg+100mg+1000mg).
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