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Tag: cdsco

You Searched For "cdsco"
Not a Nice Time For Dr Reddys? DTAB, CDSCO Recommends Stringent Restrictions on Nimesulide

Dr.Reddy's Labs gets CDSCO Panel Nod To Manufacture, Market anti-cancer drug Lenalidomide 20mg additional strength

Dr. Divya Colin19 April 2024 6:00 PM IST
New Delhi: The drug major Dr Reddy's Labs has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Akums Drugs, Tamil Nadu Agricultural University collaborate for pharmaceutical innovation

Reduce PSA level to less than 4 in inclusion criteria: CDSCO Panel Tells Akum Drugs and Pharmaceuticals on FDC Dutasteride plus Silodosin

Dr. Divya Colin18 April 2024 6:00 PM IST
New Delhi: Reviewing the active post-marketing surveillance (PMS) protocol of fixed-dose combination (FDC) Dutasteride plus Silodosin presented by...
Bharath Biotech Gets CDSCO Panel Nod To Manufacture Cholera Vaccine, Inactivated, Oral for 1 year age and above

Bharath Biotech Gets CDSCO Panel Nod To Manufacture Cholera Vaccine, Inactivated, Oral for 1 year age and above

Dr. Divya Colin17 April 2024 6:00 PM IST
New Delhi: Noting the outcome of inspections of clinical trial sites conducted by the Central Drug Standard Control Organisation (CDSCO), the Subject...
Glenmark Pharma USA launches Epinephrine Injection

Glenmark Pharmaceuticals Gets CDSCO Panel Nod to Study Lobeglitazone Sulfate, Glimepiride FDC Table

Dr. Divya Colin16 April 2024 6:00 PM IST
New Delhi: Glenmark Pharmaceuticals, a major pharmaceutical company, has received approval from the Subject Expert Committee (SEC) operating under the...
Torrent Pharma Receives USFDA Clearance for Pithampur Facility with VAI Classification

Torrent Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC

Dr. Divya Colin15 April 2024 6:00 PM IST
New Delhi: Reviewing the justification presented by the drug major Torrent Pharmaceutical, the Subject Expert Committee (SEC) functional under the...
JnJ to resume US VARIPULSE cases

CDSCO Panel Approves J&J's Protocol Amendment Proposal For Amivantamab, Lazertinib combination

Dr. Divya Colin14 April 2024 5:30 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Roche launches Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity

CDSCO Panel Approves Roche's Protocol Amendment Proposal For Anti-cancer Drug Atezolizumab, Lenvatinib, and Sorafenib Study

Dr. Divya Colin14 April 2024 5:15 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Delhi HC Upholds AstraZenecas Tagrisso Patent, Imposes Rs 7L Fine on Habitual Infringer for Knockoff Production

Submit analysis of clinical data of Asian, Indian Population: CDSCO Panel Tells AstraZeneca on Durvalumab

Dr. Divya Colin13 April 2024 6:00 PM IST
New Delhi: In response to the drug major AstraZeneca's proposal for the approval of additional indication of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL...
Lupin unveils pregnancy prevention drug Minzoya in US

Lupin Gets CDSCO Panel Nod to Study Glycopyrronium Bromide, Vilanterol Trifenatate powder for inhalation in capsule

Dr. Divya Colin13 April 2024 5:30 PM IST
New Delhi: Reviewing the Phase IV clinical trial protocol of Lupin's pulmonary FDC (Fixed Dose Combination) Glycopyrronium Bromide plus Vilanterol...
Submit global regulatory status of Atezolizumab  for IV, SC route: CDSCO Panel Tells Roche Products India

Submit global regulatory status of Atezolizumab for IV, SC route: CDSCO Panel Tells Roche Products India

Dr. Divya Colin12 April 2024 6:00 PM IST
New Delhi: In response to the proposal presented by the drug major Roche Products India for granting permission to import and market Atezolizumab...
AstraZeneca rejoins leading US drug lobby group

CDSCO Panel grants AstraZeneca's proposal for withdrawing specific Indications of Olaparib Tablets

Dr. Divya Colin11 April 2024 6:00 PM IST
New Delhi: Reviewing the Clinical evidence presented by drug major AstraZeneca, the Subject Expert Committee (SEC) functional under the Central Drug...
CDSCO panel approval to Ursodeoxycholic acid

Conduct Phase-III clinical trial: CDSCO Panel tells Abbott on Ademetionine for Injection 400mg

Dr. Divya Colin10 April 2024 6:00 PM IST
New Delhi: Responding to the proposal of import and marketing of Ademetionine for injection 400mg, the Subject Expert Committee (SEC) functional under...
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