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Add.: 1/16 Xuefu Road, Nanjing High-Tech Zone, Nanjing, P.R. China
P.C.: 210061
Tel.: 025-86990815 Fax.:025-86990701
Website: www.nkf-pharma.com
Email: nkf-pharma@nkf-pharma.com.cn
Manufacture
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With more than 30 years experience in the GMP manufacturing of Heparins and derivatives, NKF has established the state-of-the-art facility, advanced production environment, mature and robust production process, and accumulated experience and technology, which allow the company to provide long-term stable production capacity, high quality, and accurate delivery schedules.

The finished dosage production lines are built based on “Quality by Design” initiatives, which include two filling line wholly integrated into isolated systems, one for vial filling and the other one for pre-filled syringe. The utilities and other supporting systems are all with advanced configuration and compliant with cGMP requirement.

The operation process of the finished dosage production lines are controlled by computerized system, which can effectively prevent the issues due to human error. Vaporized hydrogen peroxide decontamination system, CIP/SIP and on-line environmental monitoring system can provide an aseptic production environment with high sterility assurance level inside the isolator. Life cycle validation approach is taken from process research and development, product and technology transfer, and the commercial batch manufacturing, etc. which ensure the mature and long-term reliability of the manufacturing process.

With knowledgeable management team and competent employees, and documentation system which are kept updated with current regulatory requirements and strictly adhered to at all time during production, all our products meet the most stringent quality, safety, and environmental standards globally, while maintaining consistency of productivity.

Over many years we are not only qualified sites for supply to many of the world’s largest pharmaceutical companies, but also maintains a successful quality record with global regulatory agencies.

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