Quality, quantity difficult? The quality of oxychloroquine donated by Bayer raises concerns

The antimalarial drug hydroxychloroquine, as a cheap generic, is currently a possible treatment for COVID-19But the quality of hydroxychloroquine acceptance is questioned about whether it really has anti-COVID-19 efficacyrecently, Bayer donated a batch of oxychloroquine generics, in the amount of about 3 million doses, which are currently sold under resochin's product nameOn April 17, sources told Reuters that the U.Sgovernment was increasingly concerned that the shipment of hydroxychloroquine donated by Bayer might have been produced in facilities that did not meet FDA quality standardsUnlike other FDA-approved versions of oxychloroquine, Bayer's generic version of the drug is not approved by the FDA, reuters reportedIn addition, the FDA did not inspect its production facilities, and the plant has had disturbingly serious production problems in the pastclinical demand for the drug has soared in recent weeks as U.SPresident Donald Trump has touted hydroxychloroquine in combination with the antibiotic azithromycin as a possible treatment for COVID-19And MrTrump's pursuit is not without evidencePrevious studies in France of 36 COVID-19 patients (6 asymptomatic, 22 with upper respiratory tract infection symptoms, 8 cases of lower respiratory tract infection) showed that, in contrast to 16 patients, 20 patients received 600 mg of hydroxychloroquine treatment daily, and according to their Clinical performance of combined azithromycin treatment, the results showed that patients treated with hydroxychloroquine in combination with azithromycin in the 6th day of the nasopharyngeal swab virus conversion rate of 100%, the rate of transfemininity of patients treated with hydroxychloroquine monotherapy was 57.1%, while the control group's conversion rate was only 12.5%Major pharmaceutical companies such as Bayer, Mylan and Novartis have committed millions of inexpensive oxychloroquine generics to emergency use and support a series of ongoing clinical trialsBayer's hydroxychloroquine comes from its plants in Karachi, India and PakistanWhen Bayer's plant in Karachi, Pakistan, was inspected in 2015, the country's regulator said there had been "serious errors in the production of its medicines," Reuters saidanother Resochin plant in India, operated by Indian drugmaker Ipca Labies, but the plant has not yet been approved by the FDAIpca Laboratories has previously clashed with the FDA during the FDA's inspection of other Indian plants that produce chloroquine, hydroxychloroquine and its active ingredients The FDA also imposed a five-year ban on products from three Ipca manufacturing plants in 2015 because of the drugmaker's data manipulation and falsification of records But the restriction was broken in the face of a drug shortage, and the FDA said in late March it would lift a five-year ban on products from Ipca's Indian plant so it could ship hydroxychloroquine sulphate, chloroquine phosphate and hydroxychloroquine sulfate tablets to the United States to ensure domestic treatment needs Despite many approved generics of hydroxychloroquine, the United States has fewer and fewer drug stocks and apiens In the context of the rapid spread of COVID-19, global resources tend to be scarce India, the largest producer of hydroxychloroquine, had previously banned the export of the drug and its active ingredients Ipca and Natco, another Indian drugmaker, are the only two u.S suppliers of chloroquine drugs, according to a March report by Jefferies analysts At the same time, Ipca is still supplying oxychloroquine and chloroquine to the Indian market, which are currently one of the largest in the supply, and both pharmaceutical companies are supplying both of them internally Ipsa said the FDA approved its drugs as an import alert exception because of a shortage of antimalarial drugs However, in dealing with drug shortages, factory inspections and drug quality cannot be guaranteed to be the root cause of the current problem The U.S government has chosen the former in the trade-off between quantity and quality, but quality problems will follow reference source: Bayer version of COVID-19 antimalarial dydl may come with quality s: report