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  • Phase III CT

Tag: phase iii ct

You Searched For "Phase III CT"
CDSCO Panel nod to MSN Labs Tolvaptan Tablets

MSN Laboratories Gets CDSCO Panel Nod To study Brexpiprazole Tablets

Dr. Divya Colin2 May 2025 6:00 PM IST
New Delhi: Considering the bioequivalence study of Brexpiprazole Tablets 0.25mg /0.5 mg/1mg/2mg/3mg/4mg, the Subject Expert Committee (SEC) functional...
Cipla arm Medispray Goa facility classified as VAI by USFDA

Cipla gets CDSCO Panel nod to study Revefenacin Inhalation solution

Susmita Roy20 April 2025 6:00 PM IST
New Delhi: The pharmaceutical major Cipla has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Delhi HC grants relief to zydus healthcare in biochem trademark case

CDSCO Panel suggests revising phase III CT protocol of Zydus Healthcare's Empagliflozin plus Metoprolol Succinate FDC

Dr. Divya Colin15 March 2025 6:00 PM IST
New Delhi: Considering the bioequivalence (BE) study report presented by Zydus Healthcare for the fixed dose combination of empagliflozin plus...
CDSCO panel approval to Ursodeoxycholic acid

Abbott India Gets CDSCO Panel Nod To Conduct Phase III CT of Ursodeoxycholic Acid tablet

Dr. Divya Colin6 Jan 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 the drug...
Delhi HC grants relief to zydus healthcare in biochem trademark case

CDSCO Panel rejects Zydus Healthcare's proposal to waive Phase III CT of Diphenhydramine, Phenylephrine FDC

Dr. Divya Colin30 Dec 2024 5:45 PM IST
New Delhi: Denying the proposal for a phase III clinical trial (CT) waiver, the Subject Expert Committee (SEC) functional under the Central Drug...
Intas Gets CDSCO Panel Nod for Pertuzumab

Intas Pharmaceuticals Gets CDSCO Panel Nod to Study R-hFSH Solution for Injection

Dr. Divya Colin10 Nov 2024 6:00 PM IST
New Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Intas Gets CDSCO Panel Nod for Pertuzumab

Intas Pharmaceutical Gets CDSCO Panels Nod to Conduct Phase III clinical trial of Ruxolitinib cream

Dr. Divya Colin3 Nov 2024 5:00 PM IST
New Delhi: Intas Pharmaceutical has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Delhi HC Upholds AstraZenecas Tagrisso Patent, Imposes Rs 7L Fine on Habitual Infringer for Knockoff Production

AstraZeneca gets CDSCO Panel nod to study Budesonide, Glycopyrronium and Formoterol Fumarate

Dr. Divya Colin20 Oct 2024 5:45 PM IST
New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Dr. Reddys Lab gets CDSCO Panel nod to study Semeglutide injection

Dr. Reddy's Lab gets CDSCO Panel nod to study Semeglutide injection

Dr. Divya Colin10 Aug 2024 6:00 PM IST
New Delhi: In line with the bioequivalence study report of Semaglutide Injection 2mg/1.5ml (1.34mg/ml) and 4mg/3ml (1.34mg/ml) (Synthetic Origin)...
Eli Lilly Alzheimers drug rejected by EU regulator

Eli Lilly Gets CDSCO Panel Nod to Study Retatrutide

Dr. Divya Colin1 Aug 2024 6:00 PM IST
New Delhi: Pharmaceutical major Eli Lilly has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Submit AE and SAE Data : CDSCO Panel Tells MSN Pharmaceuticals on Anti-cancer Drug MK-1084

Submit AE and SAE Data : CDSCO Panel Tells MSN Pharmaceuticals on Anti-cancer Drug MK-1084

Dr. Divya Colin25 July 2024 6:00 PM IST
New Delhi: Reviewing phase 3 clinical study protocol of the anti-cancer drug MK-1084, the Subject Expert Committee (SEC) functional under the Central...
CDSCO Panel advises Dr Reddys Laboratories to Revise Phase III CT Protocol for Live Attenuated Varicella Vaccine study

CDSCO Panel advises Dr Reddy's Laboratories to Revise Phase III CT Protocol for Live Attenuated Varicella Vaccine study

Dr. Divya Colin15 Jun 2024 6:00 PM IST
New Delhi: Reviewing the Phase III clinical trial protocol presented by the drug major, Dr Reddy's Laboratories, the Subject Expert Committee (SEC)...
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