Aurobindo Pharma Limited headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.
Scientists from the Council of Scientific and Industrial Research (CSIR) have found great success in developing a new kit for rapid testing of Covid-19. It is a paper-strip based test kit developed by scientists of CSIR-affiliated Institute of Genomics and Embedded Biology (IGIB), New Delhi, to detect infection of Covid-19 in a short time.
The tuberculosis (TB) vaccine, Bacillus Calmette-Guerin (BCG), could be a potential weapon in combatting the deadly coronavirus according to findings published by NYIT College of Osteopathic Medicine (NYITCOM) researchers, led by Gonzalo Otazu, Ph.D., assistant professor of biomedical sciences.
In order to scale up the operations and escalate faster delivery of testing kits for the novel coronavirus (Covid-19), Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd has partnered with Serum India’s CEO Adar Poonawalla and Abhijit Pawar, Chairman of APG. Funds invested will be used for scaling production of COVID-19 testing kits and expansion of molecular diagnostic solutions.
Hydroxychloroquine is taken under schedule H1 of Drugs and Cosmetics rules by central government to prevent misuse and regulate sales of hydroxychloroquine. Hydroxychloroquine is anti-malarial medicine and known to have certain effects on novel corona virus infection (COVID-19) as per clinical trials.
The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed.
EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. As of today, the Agency will no longer provide printed certificates but only electronically signed and authenticated certificates to maintain EMA’s ability to provide these documents during the COVID-19 pandemic.
Supporting the rapid development and approval of effective and safe treatments for and vaccines against COVID-19 is EMA’s top priority to help save lives during the pandemic. Over recent weeks and months, the Agency has engaged with many developers of therapeutic medicines and there are a number of developments underway. However, at this point, on the basis of the preliminary data presented to the Agency, no medicine has yet demonstrated efficacy in treating COVID-19.
Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is being recalled due to product complaints received due to ampules breaking and shattering, upon opening, during compounding.