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ABOUT USAffiliated to SSY Group Limited, Hebei Guangxiang Technology Co., Ltd., is a high-tech enterprise specializing in drug research and technology development.
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INNOVATIONSSY Group Limited has built a relatively perfect scientific research and innovation system with the synergy between “industry, academia, research and application” based on multi-disciplinary integration and multi-directional combination.
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SUBORDINATEThe group has decided to establish research institutes in its subsidiaries, Hebei Ghuangxiang Drug Research Institute, Jiangsu Best Medical Material Research Institute, and Hebei Hanlin Biological Research Institute.
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RECRUITWe actively establish a joint talent cultivation mechanism between schools and enterprises, and currently have over 500 high-level talents in various fields such as drug research, analysis, and clinical practice.
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CONTACTWe will continue to strengthen innovation-driven development, vigorously promote the integration of production and research, constantly improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs.
Bosheng: Leading the pharmaceutical packaging materials industry
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Time：2019-08-17
2019 was a special year for Bosheng. The company was founded in 2001, and now it has already marked the completion of exactly 18 years. These have been 18 years of hard work and twists and turns—a journey during which Bosheng has steadily cultivated its success through relentless effort and dedication. Over these 18 years, Bosheng has grown from nothing to something, from small beginnings to a major player, standing out brilliantly in an intensely competitive market. Today, Bosheng is in its prime, enjoying a golden period of development. We have every reason to believe that, leveraging our own technological strengths in pharmaceutical packaging materials and with the support of the Group, Bosheng’s future holds great promise.
Company Profile of Bosheng Co., Ltd.
Jiangsu Bosheng Medical New Materials Co., Ltd. (hereinafter referred to as Bosheng Company) was established in 2001 and is a high-tech enterprise specializing in the production of innovative pharmaceutical packaging materials, including pharmaceutical butyl rubber stoppers (including coated stoppers), polyisoprene gaskets, and multilayer co-extruded medical infusion films. Currently, it serves as the leading unit of the Pharmaceutical Rubber Stopper Professional Committee of the China Pharmaceutical Packaging Association.
Multiple products have been registered through the U.S. FDA’s DMF filing, and all products have obtained NMPA registration. The company’s trademark “BEST” has been awarded the title of “Well-Known Trademark of Jiangsu Province,” and its products have been recognized as “Famous Brand Products of Jiangsu Province.” The R&D center has been designated as a “Provincial Enterprise Technology Center,” a “Provincial Engineering Technology Research Center,” and a “Key R&D Institution of Jiangsu Province.” In total, eight products have been certified as “High-Tech Products of Jiangsu Province.” The company is also a participating research unit for the National Torch Program project (special rubber stoppers for ceftriaxone sodium) and a key national new product (poly-p-xylene-coated rubber stoppers).
The vitality of pharmaceutical packaging material enterprises stems from closely keeping pace with market trends and continuously meeting customers’ high standards and emerging requirements for pharmaceutical packaging materials. As China’s healthcare system reform continues to deepen, pharmaceutical preparations are being affected by new healthcare policies such as the consistency evaluation of generic drugs and centralized drug procurement.
Pharmaceutical industry
“Integration will accelerate; the joint review and approval process for excipients, packaging materials, and pharmaceutical formulations also means that pharmaceutical packaging material companies will face a survival-of-the-fittest scenario. For Bosheng, this presents both opportunities and challenges,” said Yao Guoyuan, General Manager of Bosheng Company.
In 2015, after being acquired by Siyao Pharmaceutical, Bosheng entered a stage of high-quality development. In 2018, the company achieved an 11% year-on-year increase in sales revenue, a 21% year-on-year increase in profits and taxes, and a 31.3% year-on-year increase in rubber stopper sales—performance that outperformed the industry average.
Analyzing Boshen Company’s achievement of growth in both volume and price against the market trend, we can summarize that the primary reason lies in its unwavering commitment to producing high-quality products. “We’ve been able to attain such outstanding results precisely because we’ve won over the market with our high-quality products,” said General Manager Yao Guoyuan confidently in an interview with the author. Continuously enhancing the competitive edge of product quality is Boshen Company’s steadfast and unrelenting pursuit.
Quality builds competitiveness.
“Market competition shows no mercy—only quality can serve as the cornerstone of cooperation. We simply cannot afford even the slightest flaw in our reputation for quality and integrity. Only when our products are truly top-notch can we speak with confidence and win the favor of our customers,” said Chen Dahong, head of the Quality Department. For a long time, Bosheng has consistently implemented a rigorous quality-control system throughout its production and operations, primarily through establishing internal quality standards, conducting supplier audits, and performing stringent incoming-inspection procedures to ensure the quality of raw materials. We strictly adhere to four critical checkpoints: First, we rigorously control procurement by thoroughly vetting and regularly evaluating suppliers’ qualifications and creditworthiness; second, we maintain a strict inspection process, refusing to allow any substandard raw materials or auxiliary materials into the factory; third, we carefully monitor the feeding stage, ensuring that any intermediate products failing to meet quality standards are not allowed to proceed to the next stage of production—and we strictly follow production process standards and operating procedures; and fourth, we enforce a zero-tolerance policy at the point of shipment, firmly ensuring that no substandard products leave the factory.
BoSheng Company has established a well-documented and comprehensive quality management system in strict accordance with the requirements of the new GMP standards. It has also assigned QA personnel to each workshop to provide full-process supervision over process flows, environmental cleanliness, and production procedures, and promptly correct any operational deviations. Through rigorous multi-level checks, the company has effectively prevented the entry of nonconforming raw materials into the plant, the flow of nonconforming semi-finished products into subsequent processes, and the shipment of nonconforming finished products.
At the inner packaging station for rubber stoppers, the author noticed that the production environment here closely resembled that of the intravenous solution manufacturing workshop at Siyao. The cleanliness standards were exceptionally stringent—could it be that the cleanliness level of this tiny rubber stopper production environment actually matched that of the intravenous solution preparation facility? The head of the Quality Department seemed to sense the author’s curiosity and explained: “In our pursuit of even higher quality, we’ve actively aligned our production environment with pharmaceutical GMP standards. Production takes place in cleanrooms, and certain localized areas even meet Class A standards under a Class C background—exactly the same as the production environment at pharmaceutical factories. We’re always committed to achieving the ultimate in product quality, so naturally, our quality is beyond any doubt.” Chen Dahong’s words lingered long in the author’s ears.
Deep integration of software and hardware drives intelligent manufacturing.
In the field of pharmaceutical packaging materials, with the widespread adoption of highly automated and intelligent equipment, it has become evident that the advantages extend beyond mere cost reduction—they also play a significant role in optimizing production processes and enhancing product quality.
Recognizing this point, with strong support from the Group, Bosheng has benchmarked itself against world-class standards, introducing advanced foreign production and testing equipment. It now boasts some of the most advanced film-blowing and slitting equipment in the world. Its online inspection and feedback system effectively ensures that any deviations in the quality of infusion films are promptly corrected. Bosheng also operates an advanced automated rubber stopper production line. Its manufacturing workshops are designed and built strictly according to GMP standards. It has taken the lead in the industry by adopting a no-clean rubber stopper production process and is equipped with a four-stage separation multi-effect distillation WFI system for water for injection, featuring online TOC monitoring. This guarantees that the quality of its no-clean rubber stoppers meets CP, EP, and USP standards. Moreover, the accompanying online automatic full-inspection system for rubber stopper appearance further enhances product quality and significantly strengthens Bosheng’s “hard” capabilities in intelligent manufacturing.
In addition, Bosheng has also made great efforts to enhance its “soft” capabilities. It has adopted an intelligent information management system that ensures product quality is traceable and fully auditable. Tian Renhe, Technical Director of Infusion Film, showed the author that by simply opening the production records for a particular batch in the intelligent information management system, one can clearly view the process parameters and appearance quality of that roll of infusion film—every step of the process, including who performed it and who conducted the inspection. “This maximizes product quality assurance and truly achieves dynamic quality management,” he said.
“Highly aligned with the Group’s vision of ‘guaranteeing that projects remain state-of-the-art for fifteen years,’ Bosheng’s technological upgrade projects are not merely about updating and upgrading equipment and processes—they represent a systematic, integrated engineering endeavor.” It is precisely these intelligent approaches that have endowed Bosheng with its unique competitive edge.
Innovation injects strong momentum into enterprises.
As Zhang Luyi, Chairman of Bosheng Company, put it, “To grow bigger, we must also become stronger and better. The fundamental path to making a company stronger and better is innovation.”
Innovation capabilities continue to strengthen, and new products and advanced manufacturing processes are driving Boshi’s development. Zhang Enbo, chief engineer at Boshi Company, is thoroughly familiar with the company’s innovative achievements: Boshi was the first in China to establish a technical system for developing medical rubber stoppers, breaking the technological monopoly held by developed countries in Europe and the U.S.; it has mastered the patented vacuum deposition technology for polydimethylsiloxane coatings; the newly developed special formulation and process for cephalosporin-specific rubber stoppers have filled a domestic gap; and Boshi is the only domestic manufacturer that has mastered the technology for producing radiation-resistant rubber stoppers. Moreover, Boshi was the first in China to overcome key control technologies for multilayer co-extruded films used in intravenous solutions, and it was also the first in China to successfully develop a five-layer co-extruded composite film that does not contain PVC. Boshi has set up a production workshop dedicated to multilayer co-extruded composite films and was the first in China to obtain the registration certificate for five-layer co-extruded films issued by the National Medical Products Administration. Additionally, Boshi was among the first in China to receive registration certificates for three-layer co-extruded films used in intravenous solutions. Products such as specialized rubber stoppers for ceftriaxone sodium, coated rubber stoppers, and multilayer co-extruded films for intravenous solutions have been awarded the title of High-Tech Product by Jiangsu Province, and the coated rubber stoppers have received authorization for two invention patents.
Driven by a sustained innovation-driven development strategy, Bosheng’s products have gradually secured a leading position in the market. According to the publicly available registration information on pharmaceutical packaging materials from the National Medical Products Administration’s Center for Drug Evaluation, Bosheng’s halogenated butyl rubber stoppers for injectable solutions (brominated) and three-layer co-extruded films for intravenous infusions, along with their associated formulations, have received an A-rated review and approval—making them approved packaging materials currently used in marketed formulations. Among these, the halogenated butyl rubber stoppers for injectable solutions (brominated) were among the first batch of rubber stoppers nationwide to pass the associated review and approval process.
In 2018, Bosheng achieved a “zero” breakthrough in foreign trade by successfully replacing imported products with specialized rubber stoppers for contrast agents and exporting them in bulk to the U.S. market. Additionally, Bosheng’s pen-type syringe pistons marked the company’s first-ever direct export of packaging materials.
Industry standard formulated by Bosheng
“We’ve collectively led or participated in the development of six national or industry standards for pharmaceutical packaging materials!” Chief Engineer Zhang Enbo’s tone couldn’t hide his pride.
As the leading unit of the Pharmaceutical Rubber Stopper Professional Committee of the China Pharmaceutical Packaging Association, Bosheng has established a quality control system and standards for raw materials right from the source of medical packaging material production. It actively aligns with advanced international standards such as those set by the FDA and the European Union. Focusing closely on accelerating the healthy and sustainable development of the pharmaceutical packaging industry, Bosheng promotes the formulation and enhancement of standards within China’s pharmaceutical packaging sector. To date, Bosheng has either led or participated in the drafting of six national or industry standards for pharmaceutical packaging materials.
It is worth noting that the “Guidelines for Compatibility Studies Between Pharmaceuticals and Rubber Stoppers,” drafted and led by Chief Engineer Zhang Enbo, have been adopted by the Center for Drug Evaluation of the National Medical Products Administration as a key regulatory document for drug-related review and approval. The standard’s title has been revised to “Technical Guidance Principles (Trial) for Compatibility Studies between Chemical Pharmaceuticals and Elastomeric Seals,” thereby establishing the primary focus of future research on elastomeric sealing materials and clearly defining the direction for the development of pharmaceutical packaging material studies. The achievements made by Bosheng Company in building a pharmaceutical packaging material standards system have received high recognition from both the national drug regulatory authorities and the industry.
For Bosheng, 2019 was a special year. The company was founded in 2001, and now it has already marked the full 18th anniversary. These have been 18 years of hard work and twists and turns—a journey during which Bosheng has steadily grown from nothing to something, from small to large, and has continuously created remarkable achievements through relentless effort and dedication. Over these 18 years, Bosheng has risen above fierce market competition, emerging as a standout player. Today, Bosheng is in its prime, and its development is at its most promising moment. We have every reason to believe that, leveraging our own strengths in pharmaceutical packaging materials technology and with the support of the Group, Bosheng’s future holds great promise.
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