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Tag: cdsco

You Searched For "cdsco"
Glenmark gets CDSCO panel nod to manufacture and market COPD drug

Glenmark gets CDSCO panel nod to manufacture and market COPD drug

Dr. Divya Colin9 May 2022 6:52 PM IST
New Delhi: Based on the justification provided by the pharmaceutical major Glenmark pharmaceuticals, the Subject Expert Committee (SEC) of the Central...
CDSCO allows import of drugs with residual shelf life less than 60 percent till October 31, 2021

CDSCO allows import of drugs with residual shelf life less than 60 percent till October 31, 2021

Susmita Roy8 May 2022 12:00 PM IST
New Delhi: With an aim to ensure drug availability in sufficient quantity in the domestic market, the apex drug regulator, Central Drugs Standard...
GSK Nucala application for COPD accepted for review in China

CDSCO panel directs GSK to generate safety, immunogenicity data on Indian population for INFANRIX-IPV

Dr. Divya Colin6 May 2022 7:06 PM IST
New Delhi: Rejecting pharmaceuticals major GSK's proposal to import INFANRIX-IPV in the country without conducting a local clinical trial, the Subject...
CDSCO panel directs SII to submit safety and immunogenicity data for TB vaccine

CDSCO panel directs SII to submit safety and immunogenicity data for TB vaccine

Susmita Roy5 May 2022 7:10 PM IST
New Delhi: Rejecting the vaccine major Serum Inst. of India's proposal for emergency use authorization of rBCG vaccine for prevention of Tuberculosis...
CDSCO panel gives Emcure Pharma waiver on Phase IV CT for Lamivudine plus Dolutegravir

CDSCO panel gives Emcure Pharma waiver on Phase IV CT for Lamivudine plus Dolutegravir

Dr. Divya Colin27 April 2022 6:19 PM IST
New Delhi: Pharmaceutical major, Emcure Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under Central Drug...
Gufic Biosciences bags CDSCO approval to manufacture drug for severe fungal infections

Gufic Biosciences bags CDSCO approval to manufacture drug for severe fungal infections

Ruchika Sharma27 April 2022 12:52 PM IST
Isavuconazole for Injection 200 mg/vial is indicated for the treatment of patients who are 18 years of age and above.
Dr. Reddys gets CDSCO panel nod to study Fosravuconazole L Lysine Ethanolate Capsule

Dr. Reddy's gets CDSCO panel nod to study Fosravuconazole L Lysine Ethanolate Capsule

Dr. Divya Colin25 April 2022 8:06 PM IST
New Delhi: Granting the waiver of bioequivalence study, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO)...
Novo Nordisk bags CDSCO panel nod to study anti neoplastic drug Concizumab

Novo Nordisk bags CDSCO panel nod to study anti neoplastic drug Concizumab

Dr. Divya Colin24 April 2022 12:30 PM IST
New Delhi: In line with the drug major Novo-Nordisk's proposal for Phase IIIa clinical trial of antineoplastic drug Concizumab, the Subject Expert...
Setback: AstraZeneca proposal to market, manufacture Olaparib rejected by CDSCO panel

Setback: AstraZeneca proposal to market, manufacture Olaparib rejected by CDSCO panel

Dr. Divya Colin23 April 2022 5:03 PM IST
New Delhi: In a major setback to AstraZeneca, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has...
Biological E gets CDSCO panel nod for Corbevax EUA for 5-11 years old

Biological E gets CDSCO panel nod for Corbevax EUA for 5-11 years old

Ruchika Sharma22 April 2022 1:10 PM IST
Biological E's Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years.
CoSara Diagnostics gets CDSCO clearance for Hepatitis C Viral Load Test

CoSara Diagnostics gets CDSCO clearance for Hepatitis C Viral Load Test

Ruchika Sharma22 April 2022 11:00 AM IST
Salt Lake City: Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular...
Sun Pharma

Sun Pharma gets CDSCO committee approval for manufacturing Ranibizumab

Susmita Roy16 April 2022 3:22 PM IST
New Delhi: In a significant development, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO)...
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