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Tag: sec committee

You Searched For "sec committee"
CDSCO Panel grants Pfizers protocol amendment proposal for Tofacitinib

CDSCO Panel grants Pfizer's protocol amendment proposal for Tofacitinib

Dr. Divya Colin25 Dec 2022 4:42 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol...
Akums Drugs & Pharma opens new facility

Submit Revised CT Protocol of FDC Gabapentin,Lidocaine Gel: CDSCO panel tells Akums Drugs

Dr. Divya Colin25 Dec 2022 4:23 PM IST
New Delhi: Reviewing the justification and Phase III clinical trial protocol presented by the drug-maker Akums Drugs & Pharmaceuticals for the...
Synokem Pharama gets CDSCO panel nod to manufacture, market Naftifine HCL Cream 2%

Synokem Pharama gets CDSCO panel nod to manufacture, market Naftifine HCL Cream 2%

Dr. Divya Colin22 Dec 2022 6:00 PM IST
New Delhi: The drug major Synokem Pharmaceutical has got green signal from the Subject Expert Committee (SEC) functional under the Central Drug...
AstraZeneca Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

Conduct CT in Indian population: CDSCO Panel Tells AstraZeneca for Anifrolumab

Dr. Divya Colin19 Dec 2022 6:00 PM IST
New Delhi: Highlighting that the there is no study data available in Indian population for monoclonal antibody Anifrolumab 150mg/ml concentrate for...
USFDA nod to JnJ Tremfya for Crohns disease

CDSCO opines J&J to submit details of Anticancer Drug Teclistamab approval in EU, US

Dr. Divya Colin15 Dec 2022 6:00 PM IST
New Delhi: In response to the drug major Johnson & Johnson proposal to import and market Teclistamab sterile liquid in vial 30mg/vial and...
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

Submit in vitro data and comparative data: CDSCO Tells Dr Reddy's on Icosapent Ethyl Capsule

Dr. Divya Colin13 Dec 2022 6:00 PM IST
New Delhi: Noting that the effect of Icosapentether on the risk of pancreatitis in patients with severe hypertriglyceridemia has yet to be determined,...
AstraZeneca Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

Rationale to conduct trial of Tozorakimab is not adequate: CDSCO tells AstraZeneca

Dr. Divya Colin11 Dec 2022 6:00 PM IST
New Delhi: Citing that the rationale for conduct of the proposed trial of COPD (Chronic obstructive pulmonary disease) drug Tozorakimab is not...
Zydus Gets CDSCO Panel Nod To Study Follitropin alfa

Zydus Gets CDSCO Panel Nod To Study Follitropin alfa

Dr. Divya Colin8 Dec 2022 6:00 PM IST
New Delhi: The drug major Zydus has got a green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Cipla Gets CDSCO Panel Nod To Manufacture, Market FDC Tamsulosin plus Solifenacin

Cipla Gets CDSCO Panel Nod To Manufacture, Market FDC Tamsulosin plus Solifenacin

Dr. Divya Colin7 Dec 2022 6:00 PM IST
New Delhi: Pharmaceutical major, Cipla has got a go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Revise phase III CT protocol of Recombinant Rabies G Protein Vaccine to add safety: CDSCO Panel tells Cadila

Revise phase III CT protocol of Recombinant Rabies G Protein Vaccine to add safety: CDSCO Panel tells Cadila

Dr. Divya Colin4 Dec 2022 1:44 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the vaccine...
Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma

Sun Pharma gets CDSCO panel nod to manufacture, market Esomeprazole dual release gastroresistant tablets

Susmita Roy4 Dec 2022 1:12 PM IST
New Delhi: Pharmaceutical major Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
AstraZeneca Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

AstraZeneca gets CDSCO Panel nod to market anticancer drug Acalabrutinib

Susmita Roy3 Dec 2022 6:00 PM IST
New Delhi: In a significant development, granting the proposal presented by drug major AstraZeneca Pharma India, the Subject Expert Committee (SEC)...
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