Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Lamotrigine extended-release tablets USP in the strengths of 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg, Zydus Cadila said in a statement.
"The date for implementation of track and trace system for export of drug formulations with respect to maintaining the parent-child relationship in packaging levels and its uploading on central portal has been extended upto October 1 this year for both SSI and non-SSI manufactured drugs," DGFT has said in a public notice.
With vaccines being the need of the hour to combat the Covid-19 virus, a number of companies have come forward to develop potential candidates. Faced with surging infections every day around the globe, some companies are repurposing existing drugs to fast-track a cure. Divya Rajagopal brings you an update on corporates, governments and drug companies which are currently in a race against time to develop a vaccine.
Panic-stricken citizens are flocking to homoeopathy doctors for consultation, and also to get prescriptions for arcenium album. Manufacturers of this compound – derived from the metallic element arsenic – have been dealing with “three-times bigger orders” since the AYUSH (Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha & Homoeopathy) directive.
The transaction if completed would have positioned the Hyderabad-based firm as the second largest dermatology player and the second largest generics company in the US by prescriptions.
Novartis AG on Thursday scrapped the $1 billion sale of U.S. generic pill and skin drug assets to India's Aurobindo Pharma Ltd as regulators balked, setting back the Swiss drugmaker's shift to more profitable medicines.
Mumbai-based BDR Pharma, which makes anti-HIV and Hepatitis C medication, and LASA Supergenerics, an active pharmaceutical ingredient maker, are betting that the drug works. While BDR has started lab work to get the initial samples out, it has several hurdles to cross before the product hits the market, the biggest being getting the actual reference product shipped from China.
India will likely relax some export restrictions on pharmaceutical products soon due to intense pressure from the United States which is worried about drug shortages as the number of coronavirus cases surge.
The manufacturer and importer shall also be liable to deposit the overcharged amount along with interest thereon from the date of increase in price in addition to penalty, it added.
The Ahmedabad-headquartered company said it would contribute Rs 50 crore to the PM – CARES Fund and additional Rs 50 cr under various other initiatives concerning the pandemic.
Most vaccines go through years of tests before they hit the market; 12 to 18 months would be extraordinarily fast. The coronavirus shots moving most rapidly are made with brand-new technologies that have never proven useful in humans.
Out of 13 drugs whose exports were restricted, the government is likely to lift the ban on five including paracetamol, tinidazole, metronidazole, ornidazole, and azithromycin, people in the know of the matter said.
Intas informed that it is collaborating on the WHO-endorsed study using hydroxychloroquine, a drug that may have an effect in preventing and/or reducing symptoms of COVID-19. The global COPCOV (chloroquine / hydroxychloroquine prevention of COVID-19 in the healthcare setting; a randomised, placebo-controlled prophylaxis).
Singapore-based Sensing Self Ltd and China’s Wondfo are the only companies that have cleared the National Institute of Virology (NIV)’s validation for rapid antibody test kit that can help in the fight against Covid-19.
Hydroxychloroquine received global attention recently after US President Donald Trump made claims that the drug was effective on Covid-19 patients. India is the largest exporter of hydroxychloroquine in the world, and companies that ET spoke to also confirmed they had received requests to airlift the drug from India.
Public procurement portal GeM has created a dedicated page on its platform for medical and protective equipment like thermal scanners, biohazard bags and disinfectants to help the government fight Covid-19 pandemic.
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