With increasing transformation and upgrading of our country’s pharmaceutical industry, more and more domestic pharmaceutical enterprises starts to actively exploit foreign market, turning from bulk drug export oriented to preparation product export and market coverage also expands from limited developing regions and countries to North America, Europe and Japan, etc. developed areas and countries. Thereinto, the requirement and supervision of high-end injection medicines exporting to America market is the highest and strictest. It is understood that currently, no more than five domestic preparation enterprises can export injection to America market.
Under same quality raw material and auxiliary material conditions, the quality of medicine packaging material directly decides the quality level of China high-end injection products. Relative to glass bottle and aluminum cap, etc. medicine packaging material, the selection of medical rubber stopper influences medicine more remarkably and even is decisive to most sensitive medicine.
However, although some domestic enterprises have successively exported injection medicine to America market in recent years, nearly few people concerns the injection products exported to America and almost all people chooses the medicine packaging materials provided by foreign enterprises. On the one hand, the medicine products of foreign enterprise has certain market basis in America market which can relatively increase approve process; on the other hand, more importantly, it is lack of medicine packaging material enterprise that can be perfectly matched with high-end injection export enterprises in product R & S, regulatory affairs and market operation, etc. fields.
But such situation is thoroughly changed with the first truck of high-end injection products was delivered to America at the gate of Qilu Pharmacy Co. , Ltd on December 28, 2016, which was not only a big event of Qilu Pharmacy Co. , Ltd, but also a large breakthrough of domestic injection medicine packaging enterprises.
In the late 1980s, Jiangsu Hualan New Pharmaceutical Material Co., Ltd (former Jiangyin Lanling BottleStopper Co., Ltd) started to specialize in developing, producing and selling various injection brominated isobutylene isoprene rubber stoppers. At the beginning of the 90s, Jiangsu Hualan New Pharmaceutical Material Co., Ltd resolutely carried out medical compound file research and development under the situation that it was not familiar with common butyl rubber stoppers in domestic market and won the first compound butyl rubber stopper approval letter in domestic market. In 2005, Jiangsu Hualan firstly formulated the strategic target of business internationalization. In 2010, Jiangsu Hualan successively entered into the medical rubber stopper suppliers selection range of the World pharmaceutical giant Pfizer and realized the sales broke through 100 million compound film rubber stopper in 2016. In 2012, the compound film rubber stopper products of Jiangsu Hualan was officially put on record and initiated in America PDA. At the end of 2016, the compound film rubber stopper of Jiangsu Hualan has passed several technology verification of America PDA, standing out in fierce competition with several foreign counterparts and was adopted by domestic high-end injection production enterprises and were exported by batch. It is just recent thirty years of constant development and improvement to various types of compound film rubber stopper products that enable Jiangsu Hualan New Pharmaceutical Material Co., Ltd to master era development opportunity while maintaining the leading position of domestic medical compound film rubber stopper market and truly walked into the world industry arena.
Meanwhile, this large batch of compound film rubber stoppers of Jiangsu Hualan New Pharmaceutical Material Co., Ltd exporting to America market also marks that our country’s medicine packaging production enterprises have prepared for exploring bigger development space in the world market, not only convoying for more China high-end injection export, but also doing more active exploration for the transformation development pattern of our country’s medicine packaging material industry under common state.
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江苏华兰药用新材料股份有限公司 
