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...
Conduct BE study with innovator drug as reference product: CDSCO Panel Tells Synokem on FDC Torsemide plus Eplerenone Dr. Divya Colin30 Dec 2023 5:45 PM ISTNew Delhi: After reviewing the bioequivalence (BE) study report presented by Synokem Pharmaceutical for the fixed-dose combination Torsemide IP...
Revise BE study protocol: CDSCO Panel tells Akum Pharma on FDC of Chlorthalidone, Cilnidipine, Bisoprolol film-coated tablet Dr. Divya Colin29 Dec 2023 5:00 PM ISTNew Delhi: Citing that individual and innovators' products should be taken as a reference product in the proposed bioequivalence study protocol, the...
Dr. Reddy's Gets CDSCO Panel Nod to Study FDC Etoricoxib plus Thiocolchicoside for Export purpose Dr. Divya Colin1 Dec 2023 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...
Conduct bioequivalence study: CDSCO Panel Tells Lupin on FDC Indacaterol, Glycopyrronium inhalation powder Dr. Divya Colin28 Nov 2023 6:00 PM ISTNew Delhi: Rejecting the justification for the waiver of the bioequivalence study (BE) and Phase III clinical study of fixed-dose combination (FDC)...
Ajanta Pharma Gets CDSCO Panel Nod To Study Antihypertensive FDC Dr. Divya Colin25 Nov 2023 6:00 PM ISTNew Delhi: Ajanta Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
