DTAB Approves Notification System for Application of new drug, IND for clinical trial, BA-BE study Dr. Divya Colin11 May 2025 5:45 PM ISTNew Delhi: With an aim to streamline the process for permission to manufacture new drugs and investigational new drugs (IND) for clinical trials,...
Torrent Pharmaceutical gets CDSCO Panel nod to conduct bioequivalence study of Prucalopride oral solution Dr. Divya Colin6 April 2025 2:00 AM ISTNew Delhi: Responding to the proposal presented by Torrent Pharmaceutical to manufacture and market Prucalopride oral solution 0.2 mg/ml, the Subject...
Zydus Lifesciences gets CDSCO panel nod to conduct bioequivalence study of Eltrombopag for oral suspension Dr. Divya Colin3 April 2025 6:00 PM ISTNew Delhi: Zydus Lifesciences has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
Windlas Biotech Gets CDSCO Panel Nod To study Bisoprolol Fumarate, Telmisartan, Chlorthalidone FDC Dr. Divya Colin26 March 2025 6:15 PM ISTNew Delhi: Windlas Biotech has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
Mankind Pharma gets CDSCO Panel nod for bioequivalence study of Resmetirom Tablets Dr. Divya Colin23 March 2025 6:00 PM ISTNew Delhi: Rejecting the Phase III clinical trial waiver for Resmetirom tablets 60 mg, 80 mg, and 100 mg, proposed by Mankind Pharma, the Subject...
Hetero Labs Gets CDSCO Panel Nod To Study Antipsychotic Drug Brexpiprazole Tablets Dr. Divya Colin21 Feb 2025 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Hetero...
Exemed Pharmaceutical Gets CDSCO Panel Nod To Study Elobixibat Tablets 5mg Dr. Divya Colin19 Jan 2025 6:00 PM ISTNew Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
BDR Pharmaceutical Gets CDSCO Panel Nod for Bioequivalence Study of Elobixibat tablet Dr. Divya Colin1 Jan 2025 5:45 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug...
BDR Pharmaceuticals Gets CDSCO Panel Nod for bioequvalence study of Abiraterone Acetate Oral Suspension Dr. Divya Colin25 Dec 2024 6:15 PM ISTNew Delhi: BDR Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Bisoprolol, Telmisartan, Chlorthalidone FDC: CDSCO asks Windlas Biotech to submit new BE protocol Dr. Divya Colin10 Oct 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined Windlas Biotech to...
Exemed Pharmaceuticals gets CDSCO Panel nod to study Sacubitril plus Valsartan film-coated sustained release tablet Dr. Divya Colin4 Oct 2024 6:00 PM ISTNew Delhi: Reviewing the justification for the variability of the kinetic data of the bioequivalence (BE) study report of the fixed-dose combination...
MSN Laboratories gets CDSCO Panel nod to conduct Bioequivalence Study of Abiraterone Tablets1000mg Dr. Divya Colin18 Aug 2024 5:45 PM ISTNew Delhi: MSN Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
