公司简介

n       公司概况

华北制药凯瑞特药业有限公司的前身为华北-安万特药业有限公司。由德国安万特投资有限公司与中国华北制药集团有限责任公司出资兴建。1995年二月在河北省工商局注册，注册资本为1520万德国马克，双方各占50%。总投资为2500万德国马克。

       公司位于河北省省会石家庄经济技术开发区，占地面积60000M² (其中:预留27000M²)。厂房面积8333M²。

       公司严格按照美国FDA的cGMP标准和欧洲GMP标准设计，建设有粉针车间和口服固体制剂车间。相关生产及质检设备均从德国、芬兰和美国等世界著名厂商进口，如Bosch 、Glatt、Fette及Uhlmann等。

       粉针车间于1998年投产，开始生产凯福隆。口服固体制剂车启动于2004年，2005年顺利通过GMP认证。公司遵循严格的维护保养计划，始终确保工厂及设备的运行处于高质量水平（”State of the Art”）。

n        The Company

NCPC Create Pharma Co., Ltd. grows out of Aventis-Huabei Pharma Co., Ltd that is a joint-venture of Aventis Investment Company and North China Pharmaceutical Group Corporation. The Company is registered in Hebei Industrial and Commercial Bureau in February 1995, with registered capital of 15.2 million DM paid in to equal parts by each investor. The total investment of the project is 25 million DM.

       The company locates in the Economic and Technical Development Zone of Shijiazhuang, capital of Hebei Province. The plot size is 60000M², Including  27000 M² in reserve. The size of facilities is about 8333M² 。

       The company is designed according to cGMP standards of USA’s FDA and European GMP standards and composed of two workshops of sterile powder-filling and solid preparations. The relevant machinery and equipment for manufacturing and quality testing is imported from worldwide well-known manufacturers in Germany, Finland and USA, such as Bosch、Glatt 、Fette、Uhlmann etc.

       The sterile powder-filling workshop started its operation while manufacturing Claforan^® in 1998. The solid preparation workshop started up in 2004, and successfully passed the GMP audit by State Food and Drug Administration in 2005. The “State of the Art” and highly quality level of facilities and installation is guaranteed by the permanent maintenance following a strict maintenance plan.

n      产品

凯福隆^®是公司的主要品种，由安万特公司（原德国赫司特公司）开发的世界上第一个具有高活性的三代头孢菌素产品。其对革兰阳性及阴性均有较强抗菌活性。系治疗社区获得性及医院获得性感染的最佳选择用药。

Ø        头孢菌素粉针品种有：

凯福隆^®--------注射用头孢噻肟0.5g;1.0g;2.0g

瑞呋欣^®--------注射用头孢呋辛钠 0.75g;2.0g

凯舒同^TM------注射用头孢哌酮钠舒巴坦钠（1:1）1.0g

达洛特^TM------注射用头孢哌酮钠舒巴坦钠（2:1）0.75g;1.5g;2.25g;3.0g

斯维平^TM------注射用盐酸头孢吡肟1.0g

康利沃普^TM---注射用盐酸头孢吡肟0.5g

达尼特^TM------注射用头孢尼西钠 0.5g;1.0g;2.0g

凯力定^TM------注射用头孢他啶（精氨酸） 1.0g;2.0g

Ø        口服固体制剂品种：

辅酶Q10胶囊  5mg

克林美^®--------克林霉素磷酸酯片150mg

n        Products

Claforan^® (Cefotaxime Sodium for injection) is the leading product, which is a high-active Cephalosporin, the first product of the third generation innovated and developed by Hoechst AG, the predecessor company of Aventis. Claforan has a broad spectrum of activity against aerobic Gram-positive and Gram-negative bacteria and is an excellent choice for the treatment of many community- and hospital-acquired infections.

Ø        Cephalosporins series:

       Claforan^®-Cefotaxime sodium for injection 0.5g; 1.0g; 2.0g

       Ruifuxin^®- Cefuroxime Sodium for injection 0.75g; 2.0g

       Kaishutong^TM-Cefoperazone Sodium and Sulbactam Sodium for injection (1:1)  1.0g

       Daluote^TM-Cefoperazone Sodium and Sulbactam Sodium for injection (2:1)  0.75g;1.5g;2.25g;3.0g

       Kangliwopu^TM- Cefepine Dihydrochloride for injection 0.5g    

       Siweiping^TM- Cefepine Dihydrochloride for injection 1.0g

       Danite^TM- Cefonicid Sodium for injection 0.5g; 1.0g; 2.0g

       Kailiding^TM- Ceftazidime for injection (Arginine) 1.0g ; 2.0g

Ø        Solid preparations series:

Coenzyme Q10 Capsules 5mg

       Kelinmei^®- Clindamycin phosphate tablets 150mg

n      质量第一

       公司一直以达到世界级的制造标准并确保产品质量符合或超出药政机构规定或企业内控标准为己任，并由此得到了各医疗机构及病人的信任。

       在生产及检测药品过程中严格执行国际GMP标准及安万特医药公司的内部全球质量标准，已顺利通过了国家药品监督管理的GMP认证、再认证。连续三次通过安万特全球质量认证。   

公司执行严格的确认及验证系统，主要包括机器设备验证、生产过程中的环境验证、人员行为验证、生产工艺本身验证、质检方法验证以及计算机控制系统的全面验证。

公司生产的凯福隆^®原料药粉由经美国FDA批准的德国安万特医药工厂提供，主要包装材料均由经过质量审计并获批准的供应商供货，其中内包装材料来自美国及德国的优秀生产商。

公司的质量保证体系及安万特医药公司全球审计部门的定期内部审计确保了公司生产的凯福隆及其它产品最终能够实现“质量第一”的庄严承诺。

n        Quality First

       The company is committed to achieving world-class manufacturing standards and ensuring that the quality of the product consistently meets or exceeds the requirements of regulatory agencies and own internal standards, thus gaining the confidence of medical practitioners and patients.

       The company strictly follows the international GMP’s and internal global quality standards of Aventis Pharma during manufacturing and testing of its drug. As result, the company successfully passed the GMP audits and re-audit and for three times in succession, has passed the internal audits by the Aventis Pharma International Audit Department.

The company has implemented a strict qualification/validation system that includes machinery and equipment, environment of the manufacturing process, personal and the manufacturing process itself, as well as quality test methods and computerized systems.

       The active material for Claforan^® is supplied by the FDA/USA approved Aventis Pharma production facility in Germany. The packaging material is only purchased from audited and approved suppliers, whereas the primary packing materials are imported from USA and German manufacturers.

The Quality Assurance System of the company and the regular internal audits of the Aventis Pharma international Audit Department finally guarantee that Claforan and other products manufactured at the company site meet the commitment of QUALITY FIRST.

n      质量政策和原则

在任何情况下，我们将遵循更高或更严格的质量法规标准。

面临遵循上述原则与不利的销售盈利之间的选择，我们将永远坚守质量原则。

所有员工将对其工作质量和生产的产品及提供的服务质量承担自身的责任。

所有员工都有责任不断提高生产效率和产品质量。

n        Quality Policy and Principle

Under all circumstances, we will meet or exceed the quality standard, whichever is higher or more rigorous.

When faced with a choice of adhering to the above principle or avoiding a negative sales or income consequence, the quality principle will always be honored.

All employees are personally responsible for the quality of their work and the products or services they are involved in producing or delivering.

All employees are responsible for the continuous improvement in the quality and efficiency of their work processes and products.