Conduct BE study with innovator drug as reference product: CDSCO Panel Tells Synokem on FDC Torsemide plus Eplerenone Dr. Divya Colin30 Dec 2023 5:45 PM ISTNew Delhi: After reviewing the bioequivalence (BE) study report presented by Synokem Pharmaceutical for the fixed-dose combination Torsemide IP...
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...
Dr. Reddy's Gets CDSCO Panel Nod to Study FDC Etoricoxib plus Thiocolchicoside for Export purpose Dr. Divya Colin1 Dec 2023 6:00 PM ISTNew Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Conduct bioequivalence study: CDSCO Panel Tells Lupin on FDC Indacaterol, Glycopyrronium inhalation powder Dr. Divya Colin28 Nov 2023 6:00 PM ISTNew Delhi: Rejecting the justification for the waiver of the bioequivalence study (BE) and Phase III clinical study of fixed-dose combination (FDC)...
Ajanta Pharma Gets CDSCO Panel Nod To Study Antihypertensive FDC Dr. Divya Colin25 Nov 2023 6:00 PM ISTNew Delhi: Ajanta Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
CDSCO panel rejects Akum Pharma's proposal to study Roxadustat Tablets Susmita Roy17 Sept 2023 6:00 PM ISTNew Delhi: Raising safety concerns with the drug Roxadustat, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Conduct Bioequivalence Study: CDSCO panel tells Abbott India on Dydrogesterone MR Tablets Dr. Divya Colin6 Aug 2023 6:00 PM ISTNew Delhi: Responding to the proposal for manufacturing and marketing synthetic progesterone, Dydrogesterone Modified-release (MR) Tablets presented...
Submit additional data: CDSCO Tells Laurus Labs to on Carglumic acid dispersible tablets Dr. Divya Colin17 July 2023 5:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug major...
Conduct bioequivalence Study of Elagolix tablets: CDSCO panel tells Hetero Labs Dr. Divya Colin16 July 2023 5:30 PM ISTNew Delhi: In response to the proposal presented by the drug major Hetero Labs to manufacture and market Elagolix tablet 150mg and 200mg, the Subject...
Conduct BE and Phase III CT: CDSCO Panel Tells Alkem On Elagolix Tablets Dr. Divya Colin5 May 2023 6:00 PM ISTNew Delhi: In response to the drug major Alkem Laboratories' proposal to manufacture and market the GnRH receptor antagonist Elagolix, the Subject...
Ajanta Pharma gets CDSCO Panel nod to study Tadalafil Oral Jelly for erectile dysfunction Dr. Divya Colin3 Jan 2023 5:30 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug...
Zydus Gets CDSCO panel Nod for BE Study Of Antineoplastic Drug Relugolix Dr. Divya Colin2 Jan 2023 5:30 PM ISTNew Delhi: In response to the drug major Zydus proposal for manufacture and market of anticancer drug Relugolix Tablets 120mg along with...
