Dr. Reddy’s Laboratories Ltd. and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. This will be a multicenter and randomized controlled study, which will include…
Tag: Drug Controller General of India
Cipla collaborates with Stempeutics to launch Stempeucel cell therapy
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•Cipla Limited announced that its partner Stempeutics Research Pvt. Ltd has received regulatory approval by the Drug Controller General of India (DCGI) for the launch of Stempeucel in India. The product is indicated for the treatment of ICE due to Buerger’s disease and atherosclerotic peripheral arterial disease. It is the first allogeneic cell therapy to…
Lupin launches Favipiravir drug Covihalt for COVID-19 treatment
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•Pharma major Lupin Limited announced the launch of its Favipiravir in India under the brand name Covihalt for the treatment of mild to moderate COVID-19. Favipiravir has received authorization from the Drug Controller General of India (DCGI) for emergency use, the company mentioned in its press note. Lupin’s Covihalt dosage strength has been developed keeping…
Cipla receives DCGI approval for launch of Ciplenza in India to treat mild to moderate Covid-19
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•Cipla Limited announced that it has been granted regulatory approval by the Drug Controller General of India (DCGI) for the launch of Favipiravir in the country under the brand name Ciplenza. The accelerated approval for manufacturing and marketing of the drug is aimed at meeting the urgent and unmet medical need for COVID-19 treatment options…
Wockhardt gets DCGI nod for 2 new novel antibiotics
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•The Mumbai-based global pharma company, Wockhardt, on Thursday became the first Indian company to get the Drug Controller General of India (DCGI) approval for two of its novel antibiotics, Emrok (injectable) and Emrok O (oral). The new antibiotics will be launched in the next few months in domestic as well as Chinese markets. The antibiotics…