Exemed's Sitagliptin FDC Hits Roadblock as CDSCO Panel Flags No Added Safety Benefit Parthika Patel18 Jun 2025 5:53 PM ISTNew Delhi: In a setback for Exemed Pharmaceutical, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification Dr. Divya Colin14 Jun 2025 6:19 PM ISTNew Delhi: In response to the proposal presented by Abbott, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Revise Phase IV Protocol for Gliclazide-Sitagliptin FDC with Scientific Justification: SEC Tells Eris Dr. Divya Colin4 Jun 2025 3:01 PM ISTNew Delhi: Reviewing the Phase IV clinical trial of Eris Lifesciences' Fixed Dose Combination (FDC) antidiabetic drug Gliclazide plus Sitagliptin, the...
DTAB Agrees to Prohibit 16 FDCs Identified as Irrational Farhat Nasim15 May 2025 9:02 PM ISTDelhi: In a major move to strengthen drug safety and rational prescribing practices, the Drugs Technical Advisory Board (DTAB) has recommended a ban...
DCGI Told to Act Against Unapproved Antibiotic FDCs Farhat Nasim14 May 2025 7:48 PM ISTNew Delhi: The Drugs Technical Advisory Board (DTAB), India's apex drug advisory body, has taken a firm stance on curbing the irrational use of...
FDC recalls more than 60000 bottles of glaucoma medication in US Ruchika Sharma10 May 2025 12:30 PM ISTMumbai: Mumbai-headquartered drug firm FDC Ltd is recalling 60,428 bottles of Timolol Maleate Ophthalmic Solution in the US market over...
4 Diabetes Medication FDCs including Glimipride Metformin Strength banned by Health Ministry Farhat Nasim18 April 2025 6:13 PM ISTDelhi: The Central Drugs Standard Control Organization (CDSCO) has banned the manufacture, sale, and distribution of certain widely used strengths of...
Glenmark, FDC Recall Hypertension, Glaucoma Drugs in US Farhat Nasim17 Feb 2025 8:17 PM ISTNew Delhi: Drug firms Glenmark Pharmaceuticals and FDC Ltd are recalling products in the US market due to manufacturing issues, according to the US...
NPPA Sets New Retail Price for Cilnidipine, Telmisartan Combination Farhat Nasim14 Feb 2025 4:41 PM ISTNew Delhi: The National Pharmaceutical Pricing Authority (NPPA), under the Ministry of Chemicals and Fertilizers, has revised the retail price of the...
Exemed Pharmaceutical Gets CDSCO Panel Nod To Manufacture, Market Amlodipine, Bisoprolol FDC Dr. Divya Colin28 Dec 2024 6:00 PM ISTNew Delhi: Considering the request for bioequivalence (BE) and Phase III clinical trial (CT) waiver, the Subject Expert Committee (SEC) functional...
Dr Reddy's Labs, FDC recall generic medications in US over manufacturing issues Ruchika Sharma18 Nov 2024 1:02 PM ISTNew Delhi: Dr Reddy's Laboratories and FDC Ltd, are recalling generic medications in the US over manufacturing defects. According to the US Food...
Torrent Pharmaceutical gets CDSCO Panel nod to study Gabapentin plus Duloxetine FDC Susmita Roy12 Nov 2024 5:15 PM ISTNew Delhi: Torrent Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
