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CDSCO panel tells Glenmark to submit complete clinical trial report on antidiabetic FDC Drug

Published On 2022-09-24T17:43:53+05:30  |  Updated On 24 Sep 2022 12:13 PM GMT
CDSCO panel tells Glenmark to submit complete clinical trial report on antidiabetic FDC Drug

Overview

In response to drug major Glenmark proposal to manufacture and market the antidiabetic fixed dose combination Lobeglitazone Sulphate 0.5/0.5mg plus Metformin HCL 500/1000mg ER tablets, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended Glenmark to submit the complete clinical trial report.

This came after the drug maker Glenmark presented their proposal for manufacturing and marketing of Lobeglitazone Sulphate 0.5/0.5mg plus Metformin HCL 500/1000mg ER tablets along with safety efficacy and safety data.

For more details, check out the link given below:

Submit Complete CT Report :CDSCO Tells Glenmark On Antidiabetic FDC Drug


Speakers

Dr. Nandita Mohan

BDS, MDS( Pedodontics and Preventive Dentistry)

Dr. Nandita Mohan is a practicing pediatric dentist with more than 5 years of clinical work experience. Along with this, she is equally interested in keeping herself up to date about the latest developments in the field of medicine and dentistry which is the driving force for her to be in association with Medical Dialogues. She also has her name attached with many publications; both national and international. She has pursued her BDS from Rajiv Gandhi University of Health Sciences, Bangalore and later went to enter her dream specialty (MDS) in the Department of Pedodontics and Preventive Dentistry from Pt. B.D. Sharma University of Health Sciences. Through all the years of experience, her core interest in learning something new has never stopped. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751
CDSCO Central Drug Standard Control Organization Glenmark glenmark news FDC drug Lobeglitazone Sulphate Metformin HCL ER tablets clinical trial 
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