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  • fdc

Tag: fdc

You Searched For "fdc"
Hetero Labs Acarbose-Sitagliptin-Metformin FDC Rejected by CDSCO Panel Over GI Risk

Hetero Labs' Acarbose-Sitagliptin-Metformin FDC Rejected by CDSCO Panel Over GI Risk

Dr. Divya Colin30 Jun 2025 5:45 PM IST
New Delhi: In a setback to Hetero Labs Limited, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation...
Laurus Labs Asked to Submit Justification, Data for Pediatric Darunavir-Ritonavir FDC Proposal

Laurus Labs Asked to Submit Justification, Data for Pediatric Darunavir-Ritonavir FDC Proposal

Farhat Nasim23 Jun 2025 3:30 PM IST
New Delhi: The Subject Expert Committee (SEC) on Antimicrobial & Antiviral under the Central Drugs Standard Control Organisation (CDSCO) has asked...
Sun Pharma Gets CDSCO Panel Go-Ahead to Manufacture, Market Relugolix, Estradiol, Norethindrone Acetate FDC

Sun Pharma Gets Relief on Packaging Norms for Pantoprazole-Levosulpiride FDC

Parthika Patel21 Jun 2025 4:18 PM IST
New Delhi: In a regulatory relief to the company, the Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central...
Zydus Gets CDSCO Panel Nod to Conduct Phase IV Trial for Indacaterol-Budesonide FDC Inhalation

Zydus Gets CDSCO Panel Nod to Conduct Phase IV Trial for Indacaterol-Budesonide FDC Inhalation

Dr. Divya Colin20 Jun 2025 11:45 PM IST
New Delhi: In response to the proposal presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Exemeds Sitagliptin FDC Hits Roadblock as CDSCO Panel Flags No Added Safety Benefit

Exemed's Sitagliptin FDC Hits Roadblock as CDSCO Panel Flags No Added Safety Benefit

Parthika Patel18 Jun 2025 5:53 PM IST
New Delhi: In a setback for Exemed Pharmaceutical, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
Abbott Gets SEC Nod to Market Chlordiazepoxide Tablets for Anxiety, Alcohol Withdrawal

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 IST
New 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

Revise Phase IV Protocol for Gliclazide-Sitagliptin FDC with Scientific Justification: SEC Tells Eris

Dr. Divya Colin4 Jun 2025 3:01 PM IST
New 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

DTAB Agrees to Prohibit 16 FDCs Identified as Irrational

Farhat Nasim15 May 2025 9:02 PM IST
Delhi: 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

DCGI Told to Act Against Unapproved Antibiotic FDCs

Farhat Nasim14 May 2025 7:48 PM IST
New Delhi: The Drugs Technical Advisory Board (DTAB), India's apex drug advisory body, has taken a firm stance on curbing the irrational use of...
Aurobindo Pharma recall

FDC recalls more than 60000 bottles of glaucoma medication in US

Ruchika Sharma10 May 2025 12:30 PM IST
Mumbai: Mumbai-headquartered drug firm FDC Ltd is recalling 60,428 bottles of Timolol Maleate Ophthalmic Solution in the US market over...
Adverse drug reactions from normal saline: Punjab imposes 3-year ban on Captab Biotech

4 Diabetes Medication FDCs including Glimipride Metformin Strength banned by Health Ministry

Farhat Nasim18 April 2025 6:13 PM IST
Delhi: The Central Drugs Standard Control Organization (CDSCO) has banned the manufacture, sale, and distribution of certain widely used strengths of...
Lupin recalls over 2000 bottles of antidepressant medication in US

Glenmark, FDC Recall Hypertension, Glaucoma Drugs in US

Farhat Nasim17 Feb 2025 8:17 PM IST
New Delhi: Drug firms Glenmark Pharmaceuticals and FDC Ltd are recalling products in the US market due to manufacturing issues, according to the US...
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