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DCGI nod for Jubilant’s generic remdesivir under brand name JUBI-R
expresspharma
July 21, 2020
The company will distribute the drug in the Indian market through its distribution network and will be available by the first week of August 2020.
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DCGI queries pharma company on its claim of FabiFlu use for COVID-19 patients with comorbidities
expresspharma
July 21, 2020
As per statement by the Glenmark and media reports, the DCGI had accelerated the process for clinical trials and reviews considering the pandemic situation, unmet medical conditions and unavailability of specific therapeutic management against COVID-19...
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Serum Institute gets DCGI nod for pneumococcal polysaccharide conjugate vaccine
expresspharma
July 16, 2020
The Drug Controller General of India (DCGI) has given approval to the first fully indigenously developed pneumococcal polysaccharide conjugate vaccine.
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Mylan Secures Regulatory Approval for Remdesivir Lyophilized Powder for Injection in India
americanpharmaceuticalreview
July 15, 2020
Mylan announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI's accelerated approval process to address urgent, unmet needs amid the evolving ...
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Bharat Biotech starts human trials for Covaxin, India’s first COVID-19 vaccine
expresspharma
July 15, 2020
The company had earlier received approval from the Drug Controller General of India (DCGI) to conduct phase I and II human clinical trials.
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Biophore ramps up Made-In-India Favipiravir production for Covid-19
expresspharma
July 15, 2020
Biophore has received the DCGI license to manufacture the API in India and has been cleared for export as well.
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Biocon presents key Insights into clinical study that enabled DCGI approval of Itolizumab
expresspharma
July 15, 2020
A multi-centric, open label, two-arm randomized pivotal clinical trial was conducted in 30 eligible patients at four hospitals across Mumbai and New Delhi.
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CDSCO extends consent to import drugs with less than 60 per cent residual shelf life by three months
expresspharma
July 14, 2020
The DCGI has taken this decision after considering the current situation in the country and the need for uninterrupted supply of medicines.
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DCGI approves Itolizumab for restricted emergency use in COVID-19 treatment
expresspharma
July 13, 2020
The approval was given after its clinical trials on COVID-19 patients in India was found satisfactory by an expert committee, informed the drug regulator.
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Mylan gets approval for emergency use of remdesivir for Covid-19
pharmaceutical-technology
July 08, 2020
Mylan has secured regulatory approval from the Drug Controller General of India (DCGI) for restricted emergency use of 100mg/vial remdesivir lyophilized powder to treat Covid-19.