Lupin Gets CDSCO Panel Nod To Manufacture, Market FDC of Glycopyrronium, Vilanterol Inhalation Powder Dr. Divya Colin5 Sept 2023 6:00 PM ISTNew Delhi: The drug major Lupin has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit Supportive Documents for safety of Fluticasone dose: CDSCO panel Tells Glenmark on FDC pulmonary drug Dr. Divya Colin4 Sept 2023 6:00 PM ISTNew Delhi: Based on the Phase III clinical trial protocol and justification for the inhalation toxicity of the fixed-dose combination (FDC) pulmonary...
Synokem Gets CDSCO Panel Nod to Study Antidiabetic FDC Drug Sitagliptin plus Empagliflozin Dr. Divya Colin3 Sept 2023 6:00 PM ISTNew Delhi: The drug major Synokem Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Conduct Phase-III clinical trial in India: CDSCO panel tells Johnson and Johnson Over Guselkumab Dr. Divya Colin2 Sept 2023 6:00 PM ISTNew Delhi: Citing that there is no clinical data available on the Indian Population, the Subject Expert Committee (SEC) functional under the Central...
Sun Pharma Gets CDSCO panel Nod To Manufacture, Market Sitagliptin, Metformin, Glimepiride antidiabetic FDC Dr. Divya Colin1 Sept 2023 6:00 PM ISTNew Delhi: Based on the Phase III clinical trial report and bioequivalence (BE) study report of the antidiabetic fixed-dose combination (FDC) drug...
Synokem Gets CDSCO Panel Nod To Manufacture, Market antidiabetic FDC Pioglitazone, Vildagliptin Dr. Divya Colin31 Aug 2023 6:00 PM ISTNew Delhi: With the condition of conducting phase IV clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Sun Pharma Gets CDSCO Panel Nod to Manufacture, Market Antidiabetic FDC Drug Dr. Divya Colin30 Aug 2023 6:00 PM ISTNew Delhi: Pharmaceutical major, Sun Pharma Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug...
Drug alert: 51 drug samples fail to qualify CDSCO test, 3 declared spurious Susmita Roy29 Aug 2023 2:37 PM ISTNew Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 51 medicine...
Submit interim analysis results of study in Russia and India: CDSCO panel Tells Lupin Over Aflibercept Dr. Divya Colin28 Aug 2023 6:00 PM ISTNew Delhi: In response to the proposal to enroll an additional 298 patients from India in the study of the ophthalmic drug Aflibercept, the Subject...
Submit dose Justification and international standards data: CDSCO panel Tells Synokem over Sacubitril, valsartan FDC Dr. Divya Colin27 Aug 2023 6:00 PM ISTNew Delhi: In response to the clinical trial protocol for the drug combination of sacubitril and valsartan presented by the drug maker Synokem, the...
Akums gets CDSCO Panel nod to study Gabapentin, Lidocaine FDC gel Dr. Divya Colin26 Aug 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its approval to the...
Drug Safety Alert: Indian Pharmacopoeia Commission reveals ADR linked to contraceptive drug Levonorgestrel Susmita Roy25 Aug 2023 6:00 PM ISTNew Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of August, has revealed that...
