No therapeutic justification: Central Government bans 14 FDCs for human use Susmita Roy3 Jun 2023 1:31 PM ISTNew Delhi: In accordance with the recommendation, "no therapeutic justification" made by the Expert Committee and the Drugs Technical Advisory Board,...
FDC Roha facility successfully concludes USFDA audit Ruchika Sharma29 March 2023 10:00 AM ISTMumbai: FDC has announced that the US Food and Drug Administration (USFDA) has successfully concluded the audit with no observations (Zero 483’s) at...
Synokem Pharmaceuticals gets CDSCO panel nod to conduct phase III CT of FDC Salicylic Acid plus Luliconazole Dr. Divya Colin22 Jan 2023 4:15 PM ISTNew Delhi: Drug major, Synokem Pharmaceutical has got approval from the Subject Expert Panel (SEC) functional under the Central Drug Standard Control...
Eris Lifescience gets CDSCO panel nod to study FDC of Metoprolol Succinate, Dapagliflozin Dr. Divya Colin21 Jan 2023 4:30 PM ISTNew Delhi: Directing to present bioequivalence (BE) study results in the Subject Expert Committee (SEC) before initiating the Phase III clinical...
Amend revised Phase IV CT protocol: CDSCO panel tells GSK on Respiratory Drug Combination Dr. Divya Colin3 Jan 2023 5:45 PM ISTNew Delhi: In response to the GSK's revised Phase IV clinical trial protocol for the pulmonary fixed dose combination (FDC) drug, Fluticasone...
Pure & Cure Healthcare secures CDSCO Panel nod for Phase 4 CT of Ivabradine,Metoprolol Tartrate FDC Dr. Divya Colin1 Jan 2023 5:00 PM ISTNew Delhi: Pure & Cure has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
Glenmark gets CDSCO Panel nod to Study FDC Of Bilastine, Dextromethorphan ,Phenylephrine Syrup Dr. Divya Colin12 Dec 2022 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to drug...
Cipla Gets CDSCO Panel Nod To Manufacture, Market FDC Tamsulosin plus Solifenacin Dr. Divya Colin7 Dec 2022 6:00 PM ISTNew Delhi: Pharmaceutical major, Cipla has got a go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Akum Pharma gets CDSCO panel nod to manufacture, market antihypertensive FDC drug Dr. Divya Colin27 Nov 2022 11:45 AM ISTNew Delhi: The Subject Expert Committee SEC, functional under the Central Drug Standard Control Organization CDSCO, has approved Akum Pharma to...
NPPA revises retail price of Emcure Pharma Darunavir, Ritonavir FDC Farhat Nasim3 Nov 2022 6:00 PM ISTNew Delhi: The National Pharmaceuticals Pricing Authority (NPPA) has revised the retail price of Emcure Pharmaceuticals Ltd's cocktail formulation of...
Dr. Reddy proposal to market antidiabetic FDC of Imeglimin and Vildagliptin rejected by CDSCO Panel Dr. Divya Colin2 Nov 2022 6:00 PM ISTNew Delhi: Noting that the clinical experience with the drug Imeglimin is very limited, the Subject Expert Committee (SEC) functional under the...
Glenmark gets CDSCO Panel nod to manufacture,market Lobeglitazone, Metformin antidiabetic FDC Susmita Roy31 Oct 2022 6:00 PM ISTNew Delhi: Highlighting the clinical trial results that demonstrate the efficacy and safety of combination treatment of Lobeglitazone and Metformin in...
