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Cipla proposal to market Plazomicin with clinical trial waiver rejected by CDSCO panel

Cipla proposal to market Plazomicin with clinical trial waiver rejected by CDSCO panel

Medical Dialogues Team7 Dec 2021 6:37 PM IST
New Delhi: Rejecting pharma major Cipla's proposal to import and market Plazomicin 50mg/ml injection with a local clinical trial waiver, the Subject...
Glenmark gets CDSCO panel nod to market Remogliflozin, Teneligliptin, Metformin FDC drug

Glenmark gets CDSCO panel nod to market Remogliflozin, Teneligliptin, Metformin FDC drug

Medical Dialogues Team17 Nov 2021 4:59 PM IST
New Delhi: Granting permission for a local Phase III clinical trial and bioequivalence study waver, the Subject Expert Committee (SEC) of the Central...
Parliamentary Panel Slams CDSCO for Slow Drug Approvals, Calls for Conditional Licensing in 45 Days

Dr Vishal R Tandon nominated as expert at CDSCO

Medical Dialogues Team16 Nov 2021 7:06 PM IST
New Delhi: The Ministry of Health and Family Welfare, Government of India has nominated Prof Dr Vishal R Tandon of Government Medical College Jammu as...
Glenmark gets CDSCO panel nod to import, market Akynzeo

Glenmark gets CDSCO panel nod to import, market Akynzeo

Medical Dialogues Team4 Nov 2021 11:30 AM IST
New Delhi: Granting a local clinical trial waiver, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has...
Cadila Healthcare gets CDSCO panel nod to conduct phase 3 study of  ZydCov-D in 2-dose schedule

Cadila Healthcare gets CDSCO panel nod to conduct phase 3 study of ZydCov-D in 2-dose schedule

Medical Dialogues Team29 Sept 2021 4:47 PM IST
New Delhi: In a major rejoice to Cadila Healthcare, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension

Submit detailed rationale for developing Pantoprazole modified dosage form: CDSCO panel tells Lupin

Medical Dialogues Team28 Sept 2021 6:01 PM IST
New Delhi: In response to drug-maker Lupin's proposal of manufacturing and marketing Pantoprazole enteric coated delayed release tablets 40 mg...
Bharat Biotech Covaxin efficacy 77.8 percent, gets CDSCO panel okay

Bharat Biotech Covaxin efficacy 77.8 percent, gets CDSCO panel okay

Medical Dialogues Team23 Jun 2021 1:00 PM IST
New Delhi: An expert panel of the country's central drugs authority has reviewed and accepted the phase-3 trial data of Bharat Biotech's COVID-19...
Include more Govt sites: CDSCO panel to Sanofi on clinical trial of pulmonary disease drug

Include more Govt sites: CDSCO panel to Sanofi on clinical trial of pulmonary disease drug

Medical Dialogues Team16 March 2021 9:00 AM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted permission to...
Entod Pharma directed to submit results of Phase-IV CT protocol on 25 patients to continue manufacturing Cataract FDC

Entod Pharma directed to submit results of Phase-IV CT protocol on 25 patients to continue manufacturing Cataract FDC

Medical Dialogues Team7 March 2021 12:30 PM IST
New Delhi: Manufacturer of fixed-dose combination drug Tropicamide/Phenylephrine/Lidocaine Intracameral solution for injection (0.2mg/ml + 3.1mg/ml +...
Lincoln pharma told to revise package insert before launching Sildenafil Citrate Oral Spray in Indian market

Lincoln pharma told to revise package insert before launching Sildenafil Citrate Oral Spray in Indian market

Medical Dialogues Team5 March 2021 12:17 PM IST
New Delhi: Pharma Company, Lincoln Pharmaceuticals has been directed by the Central Drugs Standard Control Organization (CDSCO) Committee to revise...
Cadila Healthcare gets CDSCO panel go-ahead for Phase 3 trial of Novel Corona Virus 2019-nCoV Vaccine

Cadila Healthcare gets CDSCO panel go-ahead for Phase 3 trial of Novel Corona Virus 2019-nCoV Vaccine

MD Bureau7 Jan 2021 5:28 PM IST
New Delhi: Pharmaceutical major, Cadila Healthcare has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control...
Rs 278 Cr Indemnity Claim, Inflated GMV, Board Ouster: Inside the Medikabazaar Controversy

AIDAN slams approval of Covaxin, expresses alarm over lack of efficacy, trial data

Farhat Nasim5 Jan 2021 4:42 PM IST
New Delhi: Slamming the recent approval of Covid-19 vaccine, Covaxin, developed by Bharat Biotech in association with the Indian Council of...
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