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Tag: cdsco panel

You Searched For "cdsco panel"
No Safety Data On Indian Populations: CDSCO panel tells Alkem over  Cefixime Oral Suspension

No Safety Data On Indian Populations: CDSCO panel tells Alkem over Cefixime Oral Suspension

Dr. Divya Colin11 Feb 2023 12:30 PM GMT
New Delhi: Rejecting the drug major Alkem's proposal for manufacturing and marketing the antibiotic drug Cefixime Oral Suspension IP 200mg/ml...
Eris Lifescience gets CDSCO panel nod to study FDC of Metoprolol Succinate, Dapagliflozin

Eris Lifescience gets CDSCO panel nod to study FDC of Metoprolol Succinate, Dapagliflozin

Dr. Divya Colin21 Jan 2023 11:00 AM GMT
New Delhi: Directing to present bioequivalence (BE) study results in the Subject Expert Committee (SEC) before initiating the Phase III clinical...
Glenmark gets CDSCO Panel nod to Study FDC Of Bilastine, Dextromethorphan ,Phenylephrine Syrup

Glenmark gets CDSCO Panel nod to Study FDC Of Bilastine, Dextromethorphan ,Phenylephrine Syrup

Dr. Divya Colin12 Dec 2022 12:30 PM GMT
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to drug...
Rationale to conduct trial of Tozorakimab is not adequate: CDSCO tells AstraZeneca

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

Dr. Divya Colin11 Dec 2022 12:30 PM GMT
New Delhi: Citing that the rationale for conduct of the proposed trial of COPD (Chronic obstructive pulmonary disease) drug Tozorakimab is not...
Submit Safety Data with Subgroup Analysis of CT: CDSCO Panel Tells Akum Pharma on Tofacitinib Oral Solution

Submit Safety Data with Subgroup Analysis of CT: CDSCO Panel Tells Akum Pharma on Tofacitinib Oral Solution

Dr. Divya Colin26 Nov 2022 12:15 PM GMT
New Delhi: Regarding the proposal for manufacturing and marketing of anti-rheumatic drug Tofacitinib Oral Solution 1mg/ml, the Subject Expert...
MSN Laboratories gets CDSCO panel nod to manufacture, market Icatibant Injection

MSN Laboratories gets CDSCO panel nod to manufacture, market Icatibant Injection

Dr. Divya Colin18 Nov 2022 12:30 PM GMT
New Delhi: Directing that the drug should be sold by retail under the prescription of the designated medical specialist only, the Subject Expert...
Sanofi gets CDSCO panel nod to market Biphasic Insulin Aspart Injection

Sanofi gets CDSCO panel nod to market Biphasic Insulin Aspart Injection

Dr. Divya Colin8 Nov 2022 12:30 PM GMT
New Delhi: With a condition of conducting a phase IV study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Dr. Reddy proposal to market antidiabetic FDC of Imeglimin and Vildagliptin rejected by CDSCO Panel

Dr. Reddy proposal to market antidiabetic FDC of Imeglimin and Vildagliptin rejected by CDSCO Panel

Dr. Divya Colin2 Nov 2022 12:30 PM GMT
New Delhi: Noting that the clinical experience with the drug Imeglimin is very limited, the Subject Expert Committee (SEC) functional under the...
Zydus Naftifine HCL 2% Cream Gets CDSCO Panel nod to treat superficial fungal infection of skin

Zydus Naftifine HCL 2% Cream Gets CDSCO Panel nod to treat superficial fungal infection of skin

Dr. Divya Colin1 Nov 2022 12:30 PM GMT
New Delhi: Pharmaceutical major, Zydus has got green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Tells MSN Lab to Produce Raw Data on Icatibant Injection

CDSCO Panel Tells MSN Lab to Produce Raw Data on Icatibant Injection

Dr. Divya Colin24 Oct 2022 7:45 AM GMT
New Delhi: In response to drug maker MSN Laboratories' justification for bioavailability (BE) study waiver for Icatibant Injection 30mg/3ml (10mg/ml)...
AstraZeneca Gets CDSCO panel nod to Import, Market Anti-Diabetic  Dapagliflozin for Additional Indication

AstraZeneca Gets CDSCO panel nod to Import, Market Anti-Diabetic Dapagliflozin for Additional Indication

Dr. Divya Colin23 Oct 2022 6:00 AM GMT
New Delhi: Pharmaceutical major AstraZeneca has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard...
SII gets CDSCO panel nod to study Pneumococcal Polysaccharide Conjugate Vaccine,Adsorbed,10-Valent

SII gets CDSCO panel nod to study Pneumococcal Polysaccharide Conjugate Vaccine,Adsorbed,10-Valent

Dr. Divya Colin21 Oct 2022 12:30 PM GMT
New Delhi: Serum Institute of India has got a go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control...
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