Chennai Apr 22 : Apex laboratories private limited receives Government of India regulatory approval for Oral Antiviral CleVira Tablets, as a supporting measure for Mild to Moderate condition of COVID-19
Manufacturing and Marketing approval granted for Clevira as a supporting measure for Mild to Moderate condition of COVID-19 as an additional indication in addition to its existing Antiviral approval.
Clevira has shown 86% recovery rate on the 5th day of treatment (86% Patients recovered – RT PCR – CT Value).
100% recovery on the 10th day of treatment.
Clinical recovery from all signs and symptoms in 4 days.
One tablet twice daily dosing convenience of oral administration.
Safe on Liver and Kidney parameters.
Marking a landmark development in the fight against COVID-19 Pandemic in India and around the globe, apex Laboratories Private Limited ,a Chennai based Pharmaceutical manufacturer and exporter known for Research, Innovation and quality medicines for more than four decades, today announced the approval of Antiviral drug Clevira as a supporting measure for Mild to Moderate condition of COVID-19.
apex laboratories private limited has received approval from Government of India (Ministry of AYUSH) regulators, for their Anti-Viral Drug Clevira as an additional indication as a supporting measure for Mild to Moderate condition of COVID-19 making it first of its kind approval in India through various stages of scrutiny at CCRAS (The Central Council for Research in Ayurvedic Sciences) and Inter Disciplinary Technical Review committee (ITRC) a 12 member technical committee constituted by Ministry of AYUSH and headed by Dr.S.K.Maulik Former Professor Department of Pharmacology AIIMS.
Clevira is the brain child of apex’s R&D Center based on proven scientific evidence and was launched in Indian market during the recent outbreak of Dengue epidemic and associated mortality in 2017. Clevira is extensively studied for its safety in animal model (Wistar rats) and efficacy in Human subjects in Phase II and III clinical trials. Clevira is an approved Antiviral formulation for the treatment of various viral infections including viral fever associated with or without thrombocytopenia. Clevira has proven for its efficacy as Analgesic, Antipyretic and reversal of thrombocytopenia apart from its Antiviral property.
A phase III Clinical trial was carried out in Government Medical Collage Omandurar Govt. Estate Chennai, based on Government approval from The State Government of Tamil Nadu. The trial outcomes revealed that Clevira has shown 86% recovery rate on 5th day of treatment in Mild to Moderate COVID-19. 100% recovery rate noticed on 10th day of treatment. Clinical recovery from all signs and symptoms was registered in 4 days. Clevira is proven to be safe on Kidney and Liver parameters.
The study outcomes were placed before the Government of Tamil Nadu, Indian Council of Medical Research (ICMR) and Ministry of AYUSH in 2020. After various stages of scrutiny and deliberations before various technical review committees, Government of India (Ministry of AYUSH) regulators have granted approval for Clevira as a supporting measure for Mild to Moderate condition of COVID-19.
Clevira is effective when taken orally and the dosage is one tablet twice daily after food for 14 days.
About apex laboratories private limited
apex laboratories private limited is more than 4 decades old Pharmaceutical manufacturer and exporter based at Chennai India, known for its flagship brands such as Zincovit, P range of Paracetamol and a whole range of branded formulations including dermatology, having global presence in over 30 countries. Research, Innovation and quality are the guiding principles of apex. It is ranked among top 50 Indian pharmaceutical companies. For more information visit www.apexlab.com
References:
CTRI/2020/05/025483
Ramesh Kannan S et al, International Journal of Innovative Research in Medical Science , Vol 04, Issue 09,Oct 2019
http://www.apexlab.com/preview-Clevira-tablets.php
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