Exemed Pharmaceutical Gets CDSCO Panel Nod to Study Empagliflozin plus Glimepiride plus Metformin FDC
New Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence (BE) study of the fixed dose combination (FDC) Empagliflozin 12.5mg/12.5mg/12.5mg/12.5mg) plus Glimepiride (1mg/1mg/2mg/2mg) plus Metformin HCl (ER) (500mg/1000mg/500mg/1000mg) film coated bilayered tablet.
This came after Exemed Pharmaceutical presented the proposal before the committee along with BE study protocol.
Empagliflozin is a sodium-glucose co-transporter (SGLT-2) class of medication for diabetes.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.
Empagliflozin works by inhibiting the sodium-glucose co-transporter-2 (SGLT-2) found in the proximal tubules in the kidneys. Through SGLT2 inhibition, empagliflozin reduces renal reabsorption of glucose and increases urinary excretion of glucose.
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