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  • bioequivalence study

Tag: bioequivalence study

You Searched For "bioequivalence study"
CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide

CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide

Dr. Divya Colin28 May 2025 3:00 PM IST
New Delhi: In response to a proposal submitted by Intas Pharmaceuticals, the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
USFDA grants Fast Track Designation to Zydus Usnoflast for amyotrophic lateral sclerosis

Zydus Lifesciences gets CDSCO Panel nod to study Aprepitant powder for Oral Suspension

Dr. Divya Colin20 May 2025 6:15 PM IST
New Delhi: Granting approval for conducting a bioequivalence (BE) study of Aprepitant powder for Oral Suspension 125 mg, the Subject Expert Committee...
Only Licensed Importers Can Overprint Labels Under Rule 104A, Clarifies CDSCO

CDSCO Panel Rejects Morepen Laboratories' Proposal To Waive local Phase III clinical trial of Resmetirom Tablet

Dr. Divya Colin18 May 2025 6:00 PM IST
New Delhi: Rejecting the proposal for the local Phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug...
Hetero Labs gets CDSCO Panel nod to study Tegoprazan tablet 50  mg

Hetero Labs gets CDSCO Panel nod to study Tegoprazan tablet 50 mg

Dr. Divya Colin13 May 2025 5:45 PM IST
New Delhi: Responding to the proposal presented by Hetero Labs, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Government doctors in Karnataka to prescribe only in-hospital medicines

DTAB Approves Notification System for Application of new drug, IND for clinical trial, BA-BE study

Dr. Divya Colin11 May 2025 5:45 PM IST
New Delhi: With an aim to streamline the process for permission to manufacture new drugs and investigational new drugs (IND) for clinical trials,...
Torrent Pharma Receives USFDA Clearance for Pithampur Facility with VAI Classification

Torrent Pharmaceutical gets CDSCO Panel nod to conduct bioequivalence study of Prucalopride oral solution

Dr. Divya Colin6 April 2025 2:00 AM IST
New Delhi: Responding to the proposal presented by Torrent Pharmaceutical to manufacture and market Prucalopride oral solution 0.2 mg/ml, the Subject...
Zydus Desidustat Gets Expert Panel Nod for Phase-III Trial in Cancer-Related Anemia

Zydus Lifesciences gets CDSCO panel nod to conduct bioequivalence study of Eltrombopag for oral suspension

Dr. Divya Colin3 April 2025 6:00 PM IST
New 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

Windlas Biotech Gets CDSCO Panel Nod To study Bisoprolol Fumarate, Telmisartan, Chlorthalidone FDC

Dr. Divya Colin26 March 2025 6:15 PM IST
New Delhi: Windlas Biotech has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
Trademark Win for Mankind: HC Rejects FLORASIS Over Similarity with FLORA

Mankind Pharma gets CDSCO Panel nod for bioequivalence study of Resmetirom Tablets

Dr. Divya Colin23 March 2025 6:00 PM IST
New 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

Hetero Labs Gets CDSCO Panel Nod To Study Antipsychotic Drug Brexpiprazole Tablets

Dr. Divya Colin21 Feb 2025 6:00 PM IST
New 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

Exemed Pharmaceutical Gets CDSCO Panel Nod To Study Elobixibat Tablets 5mg

Dr. Divya Colin19 Jan 2025 6:00 PM IST
New 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

BDR Pharmaceutical Gets CDSCO Panel Nod for Bioequivalence Study of Elobixibat tablet

Dr. Divya Colin1 Jan 2025 5:45 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug...
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