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Tag: cdsco

You Searched For "cdsco"
Akums Drugs & Pharma opens new facility

Submit Justification: CDSCO Tells Akum Pharma on Azelnidipine, Metoprolol FDC drug

Dr. Divya Colin26 Jun 2023 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Akum...
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu

Roche Gets CDSCO Panel Nod To study Anticancer FDC Pertuzumab, Trastuzumab

Dr. Divya Colin25 Jun 2023 6:00 PM IST
New Delhi: Based on the justification provided by the drug major Roche, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
CDSCO Panel Approves Pfizers  Protocol Amendment  Proposal for Marstacimab

CDSCO Panel Approves Pfizer's Protocol Amendment Proposal for Marstacimab

Dr. Divya Colin25 Jun 2023 5:30 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization CDSCO has approved the Protocol amendment...
MSN Lab Gets CDSCO Panel Nod to Manufacture, Market  Nelarabine Injection

MSN Lab Gets CDSCO Panel Nod to Manufacture, Market Nelarabine Injection

Dr. Divya Colin24 Jun 2023 6:00 PM IST
New Delhi: In a significant development, the drug major MSN Laboratories has got the green signal from the Subject Expert Committee (SEC) functional...
Exclude patients with significant cardiovascular diseases: CDSCO panel tells Hetero Labs on Polmacoxib, Paracetamol FDC

Exclude patients with significant cardiovascular diseases: CDSCO panel tells Hetero Labs on Polmacoxib, Paracetamol FDC

Dr. Divya Colin23 Jun 2023 5:41 PM IST
New Delhi: With the condition to exclude patients with significant cardiovascular diseases from the trial, the Subject Expert Committee (SEC)...
MSN Labs gets CDSCO panel nod to manufacture, market Tofacitnib Oral Solution

MSN Labs gets CDSCO panel nod to manufacture, market Tofacitnib Oral Solution

Dr. Divya Colin22 Jun 2023 4:40 PM IST
New Delhi: Granting waivers for local clinical trials and bioavailability/bioequivalence (BA/BE) studies, the Subject Expert Committee (SEC)...
Drug Alert: 27 drug samples fail to clear CDSCO test, 1 declared spurious

Drug Alert: 27 drug samples fail to clear CDSCO test, 1 declared spurious

Roshni Dhar21 Jun 2023 3:32 PM IST
In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 27 medicine batches...
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

Dr Reddy's Labs gets CDSCO panel nod to manufacture, market Ferric Carboxymaltose Inj to treat iron deficiency

Susmita Roy20 Jun 2023 5:07 PM IST
New Delhi: In a significant development, Dr. Reddy's Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the...
Health Bulletin 20/June/2023

Health Bulletin 20/June/2023

Roshni Dhar20 Jun 2023 5:02 PM IST
Here are the top health stories for the day:NEET PG Counselling to begin soon, NMC relief on existing recognised PG seats for admissions, decides on...
CDSCO Drug Alert: 27 Drug Samples flagged

CDSCO Drug Alert: 27 Drug Samples flagged

Susmita Roy19 Jun 2023 12:01 PM IST
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 27 medicine...
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe

Revise Phase IV clinical trial protocol of Nimesulide Granules for oral suspension: CDSCO Panel Tells Dr Reddys

Dr. Divya Colin18 Jun 2023 11:00 AM IST
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended the drug major Dr....
USFDA nod to Zydus Eluxadoline tablets for irritable bowel syndrome with diarrhoea

Submit safety and efficacy data: CDSCO panel Tells Zydus on Anticancer Drug Relugolix

Dr. Divya Colin18 Jun 2023 10:00 AM IST
New Delhi: In response to the drug major Zydus's proposal for the manufacture and marketing of the drug Relugolix 120 mg tablets, the Subject Expert...
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