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...
Ajanta Pharma Gets CDSCO panel conditional Nod to Manufacture, Market Cardiovascular FDC Drug Dr. Divya Colin20 Aug 2023 5:30 PM ISTNew Delhi: Citing that the proposed FDC is already approved in higher strength, the Subject Expert Committee (SEC) functional under the Central Drug...
CDSCO Panel Rejects Dr. Reddy's Proposal For Ketorolac Tromethamine plus Serratiopeptidase FDC Dr. Divya Colin7 Aug 2023 6:00 PM ISTNew Delhi: Citing there is no rationality data, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
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...
