USFDA issues EIR for Alkem Labs Baddi facility Ruchika Sharma25 Jun 2024 4:48 PM ISTMumbai: Alkem Labs has informed in a BSE filing that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report...
Alkem Labs net profit soars four-fold to Rs 293 crore in Q4 Ruchika Sharma30 May 2024 2:30 PM ISTAlkem Laboratories has announced that its consolidated net profit soared four-fold to Rs 293 crore for the March 2024 quarter, compared to a net...
CDSCO Drug Alert: 58 Drug Samples Including Alkems's Pyricool 500, Sun Pharma's Zole F Flagged Dr. Divya Colin1 April 2024 6:00 PM ISTNew Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Standard Control Organisation (CDSCO) has flagged 58 medicine...
USFDA issues ten observations for Alkem Labs Baddi facility Ruchika Sharma28 March 2024 11:29 AM ISTMumbai: Alkem Labs has announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483 with ten observations at the...
Alkem Labs gets USFDA EIR for Mandva facility Ruchika Sharma29 Feb 2024 11:54 AM ISTMumbai: Alkem Labs has announced that US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the...
Drug Safety alert: CDSCO flags 78 drug samples Roshni Dhar25 Jan 2024 5:41 PM ISTIn its latest drug safety alert, the apex drug regulatory body, Central Drug Standard Control Organisation (CDSCO) has flagged 78 medicine batches for...
Health Bulletin 25/January/2024 Roshni Dhar25 Jan 2024 4:15 PM ISTHere are the top health news for the day:Show-cause notices to 100 medical collegesAttendance shortfall of faculties is still a matter of concern for...
CDSCO Drug Alert: 78 Drug Samples including Alkem's Pan 40 Flagged Dr. Divya Colin24 Jan 2024 6:17 PM ISTNew Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drug Standard Control Organisation (CDSCO) has flagged 78 medicine...
Justify inter-subject variability in BE study data: CDSCO Panel Tells Alkem on anticancer drug Relugolix Dr. Divya Colin7 Jan 2024 5:30 PM ISTNew Delhi: Reviewing the bioequivalence (BE) study report of the anti-cancer drug Relugolix presented by the drug major Alkem Laboratories, the...
Justify dose and rationality: CDSCO Panel Tells Alkem Laboratories on FDC Sacubitril plus Valsartan Dr. Divya Colin24 Dec 2023 5:30 PM ISTNew Delhi: In response to the proposal for bioequivalence (BE) study and Phase III clinical trial (CT) waiver for Sacubitril 12mg plus Valsartan 13mg...
Modify Phase IV CT protocol: CDSCO Panel Tells Alkem on Amoxicillin, Clavulanate Oral Suspension Dr. Divya Colin20 Dec 2023 6:56 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Alkem...
USFDA issues 3 observations for Alkem Labs Mandva facility Ruchika Sharma2 Dec 2023 11:32 AM ISTMumbai: Through a recent BSE filing, Alkem Labs has informed that the Company has received Form 483 with three observations from the United...
