Pfizer gets CDSCO Panel nod to study antimicrobial FDC Avibactam plus Aztreonam Dr. Divya Colin30 Sept 2024 6:00 PM ISTNew Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Eris Lifscience Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Dr. Divya Colin29 Sept 2024 6:00 PM ISTNew Delhi: Reviewing the bioequivalence (BE) study report of the fixed-dose combination (FDC) antidiabetic drug Dapagliflozin Propanediol Monohydrate...
Drugs in CDSCO samples Counterfeit, not ours, say leading pharma companies Ruchika Sharma28 Sept 2024 3:33 PM ISTNew Delhi: After a series of media articles announcing the results of the Monthly CDSCO drug alert report and pointing how major pharma samples...
Present difference of approved and proposed formulation: CDSCO tells Novo Nordisk's Semaglutide tablet Dr. Divya Colin27 Sept 2024 6:00 PM ISTNew Delhi: In response to the proposal presented by the drug major Novo Nordisk to import and market the antidiabetic drug Semaglutide tablets 1.5 mg,...
Conduct Active Surveillance Study: CDSCO Panel Tells Pfizer on Abrocitinib tablets Dr. Divya Colin26 Sept 2024 6:00 PM ISTNew Delhi: In line with the drug major Pfizer Products proposal to waive the specific condition mentioned in the import and marketing permission of...
Torsemide, Dapagliflozin FDC not rational: CDSCO Panel Rejects Syngene's Proposal for BA/BE study Dr. Divya Colin25 Sept 2024 6:00 PM ISTNew Delhi: Noting the proposed fixed-dose combination (FDC) of 24 mg extended-release (ER) Torsemide and 8 mg Dapagliflozin Tablets is not rational;...
Submit safety data on South Asian subjects with Plaque Psoriasis: CDSCO Panel Tells Johnson & Johnson on Ustekinumab Dr. Divya Colin24 Sept 2024 6:00 PM ISTNew Delhi: In line with the proposal presented by the drug major Johnson and Johnson proposal for approval of additional indication with waiver of...
Dr. Reddy's Laboratories Gets CDSCO Panel Nod to Study FDC Telmisartan Plus Chlortalidone for Export purpose only Dr. Divya Colin23 Sept 2024 6:00 PM ISTNew Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Drug Alert: CDSCO Flags 48 Formulations As Not Of Standard Quality Dr. Divya Colin22 Sept 2024 6:00 PM ISTNew Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has flagged 48 medicine...
11 Formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert Dr. Divya Colin21 Sept 2024 6:00 PM ISTNew Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control...
Zuventus Healthcare Gets CDSCO Panel Nod To Manufacture, Market Ferrous Ascorbate suspension for iron deficiency anaemia Dr. Divya Colin20 Sept 2024 6:00 PM ISTNew Delhi: Zuventus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO releases details of Not of Standard Quality samples for 2017-2023 Dr. Divya Colin19 Sept 2024 6:00 PM ISTNew Delhi: The Central Drugs Standard Control Organization has published details of samples declared 'Not of Standard Quality' (NSQ) by Central Drugs...
