Pfizer has shut down an Indian factory! It was heshengrui who caused the disaster

Source: e pharmaceutical Manager / Tian Qi, 2016-08-11 multinational tycoons have established production bases around the world to meet their global drug supply network, but there are some differences in regulatory policies around the world In addition, the production management of factories outside Shanghai can not be achieved simply by copying Therefore, in recent years, multinational pharmaceutical companies have violated GMP in various countries Messages about regulations are becoming more common This time, another big guy hit the rocks It's his factory in India The situation of India's production base is the object of strict investigation in recent years Recently, led by the British drug and health products Regulatory Agency (MHRA), the US FDA, the Australian drug administration (TGA) and the Canadian Department of Health (HC) jointly sent inspectors to Pfizer's injection plant near Chennai, India, where they found several GMP violations Pfizer has temporarily shut down the plant A Pfizer spokesman said: "the factory will temporarily stop production and relevant experts will come to inspect and evaluate Our employees are working hard to restart production as soon as possible This suspension of production is to make a detailed plan for the inspection results, strengthen the operation management of the factory, and carry out the retraining of employees For the inspection reports submitted by FDA and MHRA, the factory has officially replied and is trying to improve the inspection results " "The factory's production is mainly for export and does not enter the U.S market." Pfizer added A spokesman for Canada's health ministry said in a statement to the media that a series of deficiencies had been found in the inspection "It is the responsibility of the company to take corrective and preventive measures against these deficiencies." 1 Heshengrui, a hidden disease, is not the foundational injection factory of Pfizer In 2009, U.S pharmaceutical company heshengrui spent $400 million in asset swaps to acquire the plant in India Last year, Pfizer's $17 billion acquisition of heshengrui brought the plant under Pfizer's management Like many of heshengrui's factories, the factory has been closely monitored by the drug regulatory agency for its poor record In 2013, the plant received a warning letter from the FDA Production management has always been the short board of heshengrui Many heshengrui factories in the United States, Europe, Asia and Australia have experienced production violations, followed by product recalls As Hershey was acquired, the problem factories were taken over by Pfizer In June, Pfizer shut down another plant from Hesheng and cut 100 jobs 2 In recent years, many multinational pharmaceutical companies have violated GMP regulations in their factories In 2015 alone, several giants were recruited: mylan's three pharmaceutical bases in India received FDA warning letter due to irregular production behavior; GSK's factory in Tianjin was withdrawn GMP certificate by European drug administration; Pfizer's factory in Dalian was found to use expired wastes and hide production records by FDA; Novartis' two plants in India were found guilty of irregularities and received FDA warning letters Most of these enterprises enjoy good reputation in the field of production and manufacturing, which has happened repeatedly in the past two years On the one hand, it shows that there is a lack of management in the manufacturing of multinational pharmaceutical enterprises in Asia On the other hand, it also shows that the inspection of major pharmaceutical regulatory agencies headed by FDA has greatly strengthened in Asia, especially in China and India This inspection is jointly conducted by four major agencies, which seems to show a trend that drug regulatory agencies in different regions will have more linkage.