CDSCO panel agrees with Sun Pharmaceutical's Phase IV Trial Results of Cephalexin plus Clavulanate Potassium Tablets Dr. Divya Colin16 May 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has agreed to the Phase IV...
Submit Data on Paracetamol-Tapentadol Combination: CDSCO Panel tells MSN Laboratories Dr. Divya Colin12 May 2024 6:00 PM ISTNew Delhi: In response to the proposal presented by MSN Laboratories for the fixed-dose combination (FDC) drug Paracetamol plus Tapentadol...
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...
Sun Pharmaceutical Industries Gets CDSCO Panel Nod to Study FDC of Relugolix, Estradiol, Norethindrone Acetate Dr. Divya Colin8 April 2024 6:00 PM ISTNew Delhi: Rejecting for clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
CDSCO Panel rejects Torrent proposal To Waive BE Study of FDC Gabapentin plus Duloxetine Dr. Divya Colin6 March 2024 6:00 PM ISTNew Delhi: Rejecting the proposal for the bioequivalence (BE) study waiver, the Subject Expert Committee (SEC) functional under the Central Drug...
Indian Pharma Market registers 8 percent surge to Rs 17,937 Crore in January 2024: IQVIA Farhat Nasim19 Feb 2024 7:19 PM ISTNew Delhi: In an impressive kickoff to 2024, the Indian pharmaceutical market surged by 8%, reaching a substantial Rs 17,937 crore in January, as per...
Conditional Approval to 5 FDCs for Continued Manufacturing and Marketing: CDSCO Susmita Roy15 Jan 2024 6:00 PM ISTNew Delhi: Through a recent notification, the Indian drug regulator, Central Drug Standard Control Organisation has notified the continued...
Sun Pharma Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug Dr. Divya Colin2 Oct 2023 6:00 PM ISTNew Delhi: Pharmaceutical major Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Submit BE study, Phase III trial protocol: CDSCO panel tells Glenmark on Metformin, Glimepiride, Lobeglitazon FDC Susmita Roy1 Oct 2023 6:00 PM ISTNew Delhi: Citing the proposed fixed-dose combination (FDC) is not approved internationally, the Subject Expert Committee (SEC) functional under the...
Provide in-vivo data, global data: CDSCO Panel Tells Glenmark on Pulmonary FDC in Inhalation Suspension Dr. Divya Colin28 Sept 2023 6:00 PM ISTNew Delhi: In reaction to the request for a waiver of bioequivalence (BE) and Phase III clinical trials for the inhalation suspension of the pulmonary...
Synokem Gets CDSCO Panel Nod to Study Antidiabetic FDC Drug Sitagliptin plus Empagliflozin Dr. Divya Colin3 Sept 2023 6:00 PM ISTNew Delhi: The drug major Synokem Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Sun Pharma Gets CDSCO panel Nod To Manufacture, Market Sitagliptin, Metformin, Glimepiride antidiabetic FDC Dr. Divya Colin1 Sept 2023 6:00 PM ISTNew Delhi: Based on the Phase III clinical trial report and bioequivalence (BE) study report of the antidiabetic fixed-dose combination (FDC) drug...
