江苏华兰药用新材料股份有限公司

 

To whom it may concern,

 

Pharmaceutical butyl rubber stopper has been used to substitute natural rubber stopper for over 3 years. In general, its reliability is stable in application of normal medications. However, in recent years, more and more pharmaceutical enterprises desire to obtain butyl rubber stopper which can guarantee safety and effectiveness of cephalosporin antibiotic during the validity (including quality of interior material and appearance and shape to adapt to automation production). Manufacturers of rubber stopper are always making rubber stoppers by constant efforts and closed cooperation by means of various technical innovation methods to satisfy pharmaceutical safety.

 

As the successful research and development of new pharmaceuticals as well as upgrading occurrence of ceclor powder preparations for injection, therapeutic drugs for transfusion and compound Chinese medicinal preparations, interior material of butyl rubber stopper has more stringent requirements, which, for manufacturers of packaging materials, is a change for technical innovation and improvement. As one of professional manufacturer of pharmaceutical packaging materials -- Lanling, we are deeply aware of the heavy responsibility.

 

As we all know, so far, for pharmaceutical rubber stoppers with proprietary formulas all over the world, clarity (turbidity) in validity of packaging of for direct contact upgrading occurrence of ceclor powder preparations for injection, therapeutic drugs for transfusion and compound Chinese medicinal preparations is seriously out of standard to varying extent, sometimes 6 months or sometimes 3 months. Some turbidity super-scale curve is in decline fast, which doesn't only bring possibility of unsafe hidden danger to patients given drugs but also brings uncertain factors to pharmaceutical safety, social stability and adverse drug reaction. In this case, the pharmaceutical enterprises and manufacturers of rubber stoppers should take responsibility for their products to the ultimate.

 

These hidden dangers are unable to deny and degree and results of the dangers are undecidable, which shall receive a lot of attention from all of us. Therefore, Lanling solemnly promises: all compound film rubber stoppers of Lanling can absolutely satisfy safety and reliability of the above mentioned preparations which are guaranteed their clarity (turbidity) will not out of limit in validity; on the contrary, butyl rubber stoppers with ordinary or proprietary formulas supplied to you won't appear such phenomenon that their clarity (turbidity) is out of limit in respective validity. So, we warn all users, in case ordinary butyl rubber stoppers are applied to the above preparations, Lanling will not assume any social, legal or economic responsibility; besides, we also ask all users to conduct compatibility test between compound film rubber stopper and medication to be packed before selecting rubber stoppers. Lanling will supply sample and services such as equipment debugging before mass production; and Lanling will also sign letter of commitment to declare turbidity won't be out of limit during its vidity as well as guarantee other quality targets.

 

Friendly remind: as both you and I shoulder the economic, legal and social responsibilities. Don't rest easy as long as some individual preparations are used out before their clarity (turbidity) is out of limit. Such attitude of being fortunate is so terrible which is do undesirable. Besides, as notified by SFDA [2008] No. 7, for future pharmaceuticals, spot check won't only conducted on site but also full inspection is required in two months before sample validity expires in order to obtain data results for the assessment of pharmaceutical safety and effectiveness.

 

As an enterprise with strong sense of responsibilities, Lanling is obliged to remind you that, it is proved by authoritative research institution that clarity (turbidity) out of limit may cause damages to user's liver and lungs and even promote growth of patient's cancer cells.

 

Public pharmaceutical safety is social and legal responsibilities that we must assume. Painful lessons were given to us in about 2006. Lanling hopes to transmit such information to you here and hope you can understand. Besides, we'll continue our wholehearted cooperation and sincere service.

                                    Jiangyin Lanling Bottle Stopper Co., Ltd

                                     President: Hua Guoping