BDR Pharmaceuticals Gets CDSCO Panel Nod for bioequvalence study of Abiraterone Acetate Oral Suspension Dr. Divya Colin25 Dec 2024 6:15 PM ISTNew Delhi: BDR Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Bisoprolol, Telmisartan, Chlorthalidone FDC: CDSCO asks Windlas Biotech to submit new BE protocol Dr. Divya Colin10 Oct 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined Windlas Biotech to...
Exemed Pharmaceuticals gets CDSCO Panel nod to study Sacubitril plus Valsartan film-coated sustained release tablet Dr. Divya Colin4 Oct 2024 6:00 PM ISTNew Delhi: Reviewing the justification for the variability of the kinetic data of the bioequivalence (BE) study report of the fixed-dose combination...
MSN Laboratories gets CDSCO Panel nod to conduct Bioequivalence Study of Abiraterone Tablets1000mg Dr. Divya Colin18 Aug 2024 5:45 PM ISTNew Delhi: MSN Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Insufficient CT data in female population: CDSCO Panel tells Alkem Laboratories on Relugolix Tablets Dr. Divya Colin31 July 2024 6:00 PM ISTNew Delhi: Noting insufficient clinical trial data in the female population for applied indication, the Subject Expert Committee (SEC) functional...
Justify Sample Size: CDSCO Panel Tells Windlas Biotech on Cardiovascular FDC Dr. Divya Colin19 May 2024 5:45 PM ISTNew Delhi: Reviewing the bioequivalence (BE) study report of the fixed-dose combination (FDC) of cardiovascular drug Bisoprolol Fumarate...
Exemed Pharmaceutical Gets CDSCO Panel Nod to Study Empagliflozin plus Glimepiride plus Metformin FDC Dr. Divya Colin7 April 2024 5:00 PM ISTNew Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee SEC functional under the Central Drug Standard Control...
Wockhardt gets CDSCO Panel nod to study Biphasic insulin aspart Dr. Divya Colin15 March 2024 5:30 PM ISTNew Delhi: Reviewing the protocol presented by the drug major Wockhardt, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Zydus Healthcare gets CDSCO Panel Nod To study FDC Empagliflozin plus Metoprolol Succinate Dr. Divya Colin10 March 2024 5:45 PM ISTNew Delhi: The drug major Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Synokem gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Sacubitril plus Valsartan Dr. Divya Colin10 March 2024 5:30 PM ISTNew Delhi: The drug major Synokem Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Justify bioequivalent data: CDSCO Panel Tells Sun Pharma on Mirabegron Extended-release Tablets Dr. Divya Colin8 March 2024 6:00 PM ISTNew Delhi: After reviewing the bioequivalence (BE) report of Mirabegron extended-release Tablets 50 mg presented by drug major Sun Pharma, the Subject...
CDSCO Panel rejects Torrent proposal To Waive BE Study of FDC Gabapentin plus Duloxetine Dr. Divya Colin6 March 2024 6:00 PM ISTNew Delhi: Rejecting the proposal for the bioequivalence (BE) study waiver, the Subject Expert Committee (SEC) functional under the Central Drug...
