In the first quarter of 2017, API exports rebounded, taking advantage of the transformation to get out of the price depression

Following the official fda notice on May 22 to lift the ban on the import of raw materials used by people at taizhou factories owned by Haizheng Pharmaceuticals, Haizheng Pharmaceuticals recently received an official FDA warning letter of closure, and the ban on the import of veterinary raw materials has been lifted. As a result, all products registered and approved by Haizheng Pharmaceuticals in the United States will be exported normally to the U.S. market.Built quality management system
According to feedback from Haizheng Pharmaceuticals, since receiving the FDA import warning and EMA "GMP Non-conformity Statement", enterprises have conducted a detailed root cause investigation of the problems found, assessed the risks and impact on product quality, and formulated corrective and preventive measures in the areas of quality culture construction, process improvement and improvement, strengthening technical means, strengthening internal supervision and management.
Regarding the results of the rectification, the FDA said in a warning letter closing notice that the FDA had completed its assessment of the defects proposed by Haizheng Pharmaceuticals in the warning letter and believed that it had taken appropriate corrective action, and therefore closed the warning letter to the company's Taizhou plant. In the future, the FDA will continue to examine and monitor the adability and sustainability of these corrective measures.
Since 2014, the FDA has stepped up its audit of overseas API manufacturers, and China, India and other major API exporters have been recruited by enterprises, received warning letters, and some API products have been banned from exporting to the U.S. market for some time, resulting in a decline in export performance to the U.S. The data show that the main reason for china's API enterprises to encounter FDA import warning is that there are problems in the quality management system of the enterprise, mainly reflected in the lack of laboratory data integrity or the existence of fraud.
" Haizheng Pharmaceuticals announced that the FDA lifted the company's import ban on raw materials, a victory for its efforts to regain FDA approval through renovations and efforts. Cao Gang, director of the Western Pharmaceutical Department of the China Medical Insurance Chamber of Commerce, said that this also gives China to seek FDA certification and access to the U.S. market of API enterprises some inspiration, that is, in strict accordance with the relevant provisions of the FDA, the relevant production lines and factories of quality and cultural construction, equipment and technical means, hardware and software and personnel reserves, internal supervision and management and other aspects should be fully prepared, seriously, to ensure that enterprises successfully through certification, products into the U.S. market.
years, China's API enterprises in the international market competition is facing many challenges. First, the transfer of raw materials industry accelerated, the production of raw materials gradually from Spain and other European countries to China, India and other relatively low production costs of countries, more competitors, industry competition tends to be fierce. Second, the global pharmaceutical industry has a vertical integration of the development trend, preparation production enterprises and API manufacturers between the increasing number of mergers and acquisitions, the world's mainstream characteristics of API enterprises are gradually to high-end preparations, patented pharmaceutical market development. With the vertical integration of API and preparation of global pharmaceutical companies, API customer base has shrunk, API sales face more intense market competition.A sustained increase in export prices fell
Data released by the China Medical Insurance Association show that in the first quarter of 2017, China's API exports amounted to US$6.722 billion, up 6.71% YoY, but there was a price reduction promotion, while the volume of exports increased by 14.21%, while the average export price fell by 6.57%. Amino acids, penicillin, hormones, cephalosporins and other bulk raw materials are still the main categories of price reduction promotion.
the same time, some API prices rose, the average price of anti-heat analgesia export bottom rebounded, vitamins continued the momentum of price increases. From the market segment, China's API exports to all continents in the first quarter are positive growth, exports to the United States, South Korea increased by more than 20% year-on-year.
" in the past two years, China's API exports show a trend of increasing and falling prices, the first quarter of this year still continued this trend. According to Cao Gang's analysis, the increase in export volume indicates that the international market still has rigid demand for Chinese API, while China's API enterprises have made hardships and efforts in response to the call of the state to promote steady growth in foreign trade, sacrificing some prices to increase export volume.
reporter learned that the reasons for the price decline also include: 1. the number of enterprises seeking to export raw materials increased, some production enterprises choose to bypass traders direct exports, some are originally only for domestic enterprises began to pay attention to the international market. According to customs statistics, the number of enterprises operating API exports increased by 675 in 2016 compared with 2014, an increase of 7% in two years. In the first quarter of 2017, the number of companies operating API exports increased by 428, or 6.4%, compared with the same period in 2016. On the one hand, the increase in the number of export enterprises led to a decline in export concentration, export bargaining power weakened, on the other hand, enterprises fighting outside the war, customers around the price.
2. Affected by local government protectionism, the reform of domestic API supply side has been slow, the results have not yet been shown, decapacity is not easy, the consequences of overcapacity continue to ferment, resulting in China's API export prices continue to fall.
. The slow global economic recovery, coupled with exchange rate fluctuations, has resulted in reduced customer capacity to pay, inadequate procurement budgets and severe price pressures.
. Trade friction cases are frequent. In 2016, the European Union and India launched a total of six cases of trade relief for API products, which adversely affected our products' subsequent entry into both markets.Transformation to enhance competitiveness
In 2016, the Chinese government issued a series of policies, involving encouraging export credit, improving processing trade policies, expanding cross-border e-commerce pilot projects, and further promoting customs clearance facilitation, so as to open the way for enterprises to stabilize trade.
At the beginning of 2017, the Ministry of Commerce, when deploying key foreign trade work, mentioned that during the year, it will continue to provide multiple assistance to reduce the burden on enterprises, accelerate the development of new industries, adjust the trade structure and create a favorable environment, and continue to care for The stability of China's foreign trade.
In addition, the successful holding of the Belt and Road International Cooperation Summit Forum in May has created a good political atmosphere for China to carry out deeper economic and trade cooperation with countries along the Belt and Road, and china's API industry exports will also benefit from it. According to Cao Gang, China's API exports will continue to pick up this year, the scale of exports continue to maintain, year-on-year or 3% to 5% growth.
some API companies are accelerating the international market layout. Recently, Arben Chemical announced that it intends to acquire a 100% stake in Malta's AMINO CHEMICALS LIMITED for 24.458 million euros. The company's existing RAW products 43 kinds, mainly to provide API production and API customization services. Yaben Chemical said that the acquisition can help the company more products through the European and American norms, mature market certification, accelerate the research of high-end pharmaceutical intermediates and specialty API products, such as industrialization.
Cao Gang suggested operating raw materials export enterprises: First, we should pay attention to innovation. Research and development of new products, new processes, with core products and key technologies, active transformation and upgrading and differentiated competition. Some domestic API export enterprises have made achievements, such as focusing on customized intermediates, customized API, specialty API research and development and production, and even into the field of preparation.
should pay attention to certification. Pay special attention to international high-end certification, not only to improve equipment, technology, software and other levels, and thus improve product quality, but also across the target market national quality standards threshold, access to the market qualifications, but also to provide quality assurance, enhance the international image.
third to pay attention to the brand. There will be a premium for brands that can enhance competitiveness and profit margins. API enterprises to build a brand needs to rely on product quality, corporate image, trade associations and other ways to make the brand become an enterprise sign, enhance added value and competitiveness.
fourth to pay attention to environmental protection. THE API industry is a high-polluting industry, after the implementation of the new environmental protection law, the original kind of environmental damage at the expense of extensive, unsustainable development model is gradually eliminated. Pollution control, environmental protection is corporate social responsibility, API production enterprises in particular should pay attention to environmental protection, from the production line construction, personnel awareness and other sources, through environmental protection to enhance the responsible image of enterprises, to avoid future environmental risks and affect the completion of API export orders and enterprise export reputation. (Medical Economics)