CDSCO panel rejects Akums Drugs Proposal for PK/PD study of Cholecalciferol aqueous injection Dr. Divya Colin27 April 2025 6:00 PM ISTNew Delhi: Noting that adequate safety measures are not incorporated in the proposed protocol, the Subject Expert Committee (SEC) functional under the...
Justify Rationality of FDC Meropenem plus Sodium Carbonate plus Avibactam: CDSCO Panel Tells Akum Pharmaceutical Dr. Divya Colin2 May 2024 6:00 PM ISTNew Delhi: Reviewing the proposal presented by the drug major Akum Pharmaceutical, the Subject Expert Committee (SEC) functional under the Central...
CDSCO Panel Rejects Akum Pharma's Clonazepam-Duloxetine Combination Drug Dr. Divya Colin18 March 2024 6:00 PM ISTNew Delhi: Reviewing the justification provided by the drug major Akum Pharmaceutical concerning the fixed-dose combination (FDC) Clonazepam plus...
CDSCO panel Rejects Akum Pharma's FDC Bempedoic acid plus Atorvastatin Calcium plus Ezetimibe Dr. Divya Colin11 March 2024 6:00 PM ISTNew Delhi: Reviewing the justification presented by the drug major Akum Pharmaceutical with respect to the triple-drug combination of Bempedoic acid...
Akums Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug Dr. Divya Colin13 Feb 2024 6:00 PM ISTNew Delhi: The drug major Akum Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Revise BE study protocol: CDSCO Panel tells Akum Pharma on FDC of Chlorthalidone, Cilnidipine, Bisoprolol film-coated tablet Dr. Divya Colin29 Dec 2023 5:00 PM ISTNew Delhi: Citing that individual and innovators' products should be taken as a reference product in the proposed bioequivalence study protocol, the...
Modify phase III clinical trial protocol: CDSCO panel tells Akum Pharma on antidiabetic FDCÂ Dr. Divya Colin17 Dec 2023 5:30 PM ISTNew Delhi: Approving to conduct the bioequivalence (BE) study of the antidiabetic drug combination Repaglinide plus Voglibose plus Metformin...
Conduct Phase III CT: CDSCO Panel Tells Akum Pharmaceutical on Antidiabetic FDC Dr. Divya Colin10 Dec 2023 6:00 PM ISTNew Delhi: Rejecting the proposal for the clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Akum Pharmaceutical Gets CDSCO Panel Nod to Manufacture, Market Azelnidipine, Metoprolol FDC tablet Dr. Divya Colin3 Dec 2023 6:00 PM ISTNew Delhi: The drug major Akum Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Modify phase IV CT Protocol: CDSCO panel Tells Akums Pharma on FDC Bempedoic acid, Rosuvastatin Calcium Dr. Divya Colin26 Nov 2023 5:45 PM ISTNew Delhi: After reviewing the Phase IV clinical trial protocol of the fixed-dose combination Bempedoic acid plus Rosuvastatin Calcium presented by...
Submit raw data linked to CT result: CDSCO Panel Tells Akum Pharma on Azelnidipine, Metoprolol FDC drug Dr. Divya Colin4 Nov 2023 5:26 PM ISTNew Delhi: Based on the justification presented by Akum Pharmaceutical with respect to the clinical trial results of the fixed-dose combination...
Akum Pharma Gets CDSCO panel Nod To Manufacture, Market Alchohol plus Ketoprofen Gel Dr. Divya Colin11 Oct 2023 6:00 PM ISTNew Delhi: The drug major Akum Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
