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Tag: cdsco

You Searched For "cdsco"
Laurus Labs Asked to Submit Justification, Data for Pediatric Darunavir-Ritonavir FDC Proposal

Submit additional data: CDSCO Tells Laurus Labs to on Carglumic acid dispersible tablets

Dr. Divya Colin17 July 2023 5:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug major...
SEC Approves Serums Salk Polio Vaccine for Commercial Use, Recommends Phase I Trial for 21-valent Pneumococcal Vaccine

Serum Institute of India Gets CDSCO Panel Nod for Phase III CT of Inactivated Salk Polio Vaccine

Dr. Divya Colin16 July 2023 6:00 PM IST
New Delhi: Based on the interim report of the Phase II clinical trial of the Inactivated Salk Polio Vaccine (Adsorbed) presented by vaccine maker...
Conduct bioequivalence Study of Elagolix tablets: CDSCO panel tells Hetero Labs

Conduct bioequivalence Study of Elagolix tablets: CDSCO panel tells Hetero Labs

Dr. Divya Colin16 July 2023 5:30 PM IST
New Delhi: In response to the proposal presented by the drug major Hetero Labs to manufacture and market Elagolix tablet 150mg and 200mg, the Subject...
Novartis oral Fabhalta gets USFDA nod for adults with C3 glomerulopathy

Novartis gets CDSCO Panel Nod To Import, Market Inclisiran solution for injection

Dr. Divya Colin15 July 2023 6:00 PM IST
New Delhi: After deliberating the interim data of a Phase-III global clinical trial of Inclisiran solution for injection presented by pharmaceutical...
Bharat Biotech Oral Cholera vaccine Hillchol​ shows success in Phase III clinical studies

Design protocol as Phase III CT for 1 to more than 50 years age group: CDSCO panel tells Bharat Biotech on JE vaccine

Dr. Divya Colin14 July 2023 6:00 PM IST
New Delhi: In response to the proposal presented by the vaccine maker Bharath Biotech to conduct the Phase IV clinical trial of the Japanese...
Biocon Biologics Yesafili gets Health Canada nod for eye diseases

Conduct Phase III CT: CDSCO Panel Tells Biocon Biologics Over Anti-cancer Drug Nimutuzumab

Dr. Divya Colin13 July 2023 6:00 PM IST
New Delhi: Observing that there is no convincing data available for the proposed additional indication for the drug Nimutuzumab, the Subject Expert...
GSK Shingrix new prefilled syringe

GSK gets CDSCO panel Nod for Phase III Extension safety follow-up study for trial of RSVPreF3 vaccine

Dr. Divya Colin12 July 2023 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug...
Akums Drugs, Tamil Nadu Agricultural University collaborate for pharmaceutical innovation

More clinical trial sites should be included: CDSCO Panel tells Akum Pharma over Letrozole tablet

Dr. Divya Colin11 July 2023 6:00 PM IST
New Delhi: Noting more clinical trial sites should be included to have geographically distributed sites across India, the Subject Expert Committee...
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu

Revise CT Protocol: CDSCO Panel Tells Roche on Ophthalmic Drug RO7200220

Dr. Divya Colin10 July 2023 6:00 PM IST
New Delhi: Responding to the drug major Roche's proposal to conduct a Phase III clinical trial of RO7200220, anti-interleukin-6 (IL-6), the Subject...
Akums Drugs & Pharma opens new facility

Akums Pharma Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug

Dr. Divya Colin9 July 2023 6:00 PM IST
New Delhi: Noting that the antidiabetic fixed-dose combination (FDC), Sitagliptin Phosphate Monohydrate 100mg/100mg plus Pioglitazone 15mg/15mg plus...
Ajanta Pharma to add liquid formulation facility at Pithampur site

Ajanta Pharma Gets CDSCO Panel Nod To Manufacture, Market Tadalafil Oral Jelly for Erectile Dysfunction

Dr. Divya Colin9 July 2023 5:30 PM IST
New Delhi: Granting the clinical trial study waiver, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization...
Akums Drugs & Pharma opens new facility

Akums Pharma Gets CDSCO Panel Nod To Manufacture, Market Tamsulosin HCL, Tadalafil FDC Tablet

Dr. Divya Colin8 July 2023 6:00 PM IST
New Delhi: The drug major Akums Drugs and Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central...
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