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...
Anti-infective for severe fungal infections: Alkem Labs joins hands with Biosergen for development of BSG005 Ruchika Sharma25 Sept 2023 2:30 PM ISTAlkem will invest in the clinical development of BSG005 and will be granted an exclusive license to market it in India.
Alkem Labs brands API business as Alkem Activa Roshni Dhar25 Sept 2023 12:41 PM ISTAlkem Laboratories Ltd. has announced the branding of their active pharmaceutical ingredients (API) business as Alkem Activa."Alkem Activa signifies a...
Health Bulletin 23/September/2023 Roshni Dhar23 Sept 2023 5:08 PM ISTHere are the top health stories for the day:NEET SS 2023 admit card outThe National Board of Examinations (NBE) has released the admit card for NEET...
Alkem Labs brands API business as Alkem Activa Ruchika Sharma22 Sept 2023 12:40 PM ISTBy forging partnerships and collaborations, Alkem Activa aims to become a reliable supplier of high- quality APIs to pharmaceutical companies...
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...
Health Bulletin 10/August/2023 Roshni Dhar10 Aug 2023 4:51 PM ISTHere are the top health stories for the day:Air we breath, and its deteriorating quality is associated with increased antibiotic resistanceCurbing...
Counterfeit medicines worth Rs 2 crore of Augmentin, Pan-D, Urimax-D and others seized from Kolkata warehouse Ruchika Sharma4 Aug 2023 2:30 PM IST"During the raid, counterfeit medicines, worth about Rs 2 crore of leading manufacturers such as Sun Pharmaceutical, Alkem, Cipla, Glenmark, GSK,...
