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About Center

Nanjing Chang Ao Pharmaceutical Co., Limited

Nanjing Chang Ao Pharmaceutical Co., Limited is located in the Intelligent Manufacturing Industrial Park in Jiangbei New District, Nanjing, Jiangsu Province. The pharmaceutical plant is a modern factory built in accordance with the EU GMP standards.
The center currently has production plants for tablets, capsules, freeze-dried powder injections and soft (cream) and gel products, and has 60 varieties with production approvals. The representative products include Aoding® (Pitavastatin Calcium Tablets), Aobo Ping® (Rabeprazole Sodium for Injection), Fushitan® (Pantoprazole Sodium for Injection/Pantoprazole sodium Enteric-Coated Capsules), Ophen® (Clarithromycin Dispersible Tablets), and Antaen® (Diclofenac Sodium Sustained Release Capsules/Gel).

The construction of the plant incorporates the concept of “quality by design” into the design of the equipment, and all equipment is designed in accordance with current Chinese GMP requirements and EU GMP requirements. The company selects domestic first-class mainstream equipment for production, and inspection instruments are purchased from world-renowned manufacturers.

Annual production capacity:
  • 360million tablets per/yearSolid preparations [tablets]
  • 300million capsules/yearSolid preparations [capsules]
  • 20million vials/yearFreeze-dried powder injections
  • 7.5million tubes/yearOintment (cream), gel
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Quality management

Since its establishment in 1997, the company has gradually improved its production and quality management system, and its organizational structure, staffing and hardware have strongly ensured the healthy operation of the quality management system.

Since the establishment of the company:
Product sampling pass - 100%  One-time pass of all GMP certifications

Innovations

Nanjing Chang Ao Pharmaceutical Co., Limited attaches great importance to the development of science and technology. In recent years, it has continuously increased its investment in scientific and technological research and development, and now has 14 invention patents (including pantoprazole sodium enteric-coated micropelets, rabeprazole sodium enteric-coated pellets and their preparation methods, a stable freeze-dried preparation of rabeprazole sodium and its preparation method, a prulifloxacin tablet and its preparation process, a preparation containing levodopa methyl ester and its preparation method).
Six products have been awarded as high-tech products in Jiangsu Province (rabeprazole sodium for injection, pantoprazole sodium enteric-coated capsules, cefpodoxime proxetil dispersible tablets, pantoprazole sodium for injection, clarithromycin dispersible tablets, irbesartan tablets).
Environment Company Environment
The company has a high sense of corporate responsibility and always takes “saving patients” as its mission, expecting to bring benefits to more patients. The company is committed to working with all partners to improve the health and quality of life
Production Workshop

Freeze-dried Powder Injection Workshop

The freeze-dried powder injection workshop covers a total construction area of 3,300 m2. It was completed and put into use in November 2013, and passed the on-site inspection by the National Bureau in June 2014. The workshop has two floors, where the first floor is a freeze-dried powder injection workshop, and the second floor is distributed with 3 purification air conditioning systems, a purified water system, a water for injection system and a pure steam system. The production area in the workshop is divided into general production area (Grade G area), Grade D clean area, Grade C clean area and Grade B clean area according to the process requirements. Lamp inspection and outer packaging are in the Grade G production area, vial washing is in the Grade D clean area, liquid dispensing, cork cleaning and sterilization, aluminum cap cleaning and sterilization, and capping are in the Grade C clean area, filling is in the Grade B clean area. The main equipment includes one washing, drying, filling and rolling line, two liquid dispensing systems (500 liters and 100 liters), 3 freeze-drying machines (total 120 m2) and an automatic feeding and unloading system, one rubber plug cleaning, sterilization and drying machine, one aluminum cover cleaning, sterilization and drying machine, 3 moist heat sterilization cabinets, 2 dry heat sterilization cabinets, 3 clean weighing rooms, with an annual production capacity of 20 million freeze-dried powder needles.
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General Solid Workshop

The general solid workshop passed the on-site inspection by Jiangsu Provincial Bureau in June 2015; the workshop covers a total construction area of 3,300 m2, and is a Grade D clean area; it produces tablets and capsules; it has a raw material sampling and pre-treatment workshop and a special purification air conditioning system and purified water system; the main production equipment includes one wet granulation line, one dry granulation machine, final blenders (200L, 600L, 1200L), 2 tablet press machines, 4 micropelets coating machines, 2 capsule filling machines, 2 coating machines, 2 aluminum packaging machines, 2 aluminum-plastic packaging machines, and one automatic packaging line, with annual production capacity of 360 million tablets and 300 million capsules.
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Topical Medicine Workshop

The topical medicine workshop was inspected on site by the Jiangsu Provincial Bureau in January 2016, where the production equipment includes one batching system (700 L), one aluminum tube filling machine and one plastic tube filling machine, with an annual production capacity of 7.5 million tubes of ointment and gel preparations.
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QC Department

The QC department is equipped with conventional testing equipment such as liquid chromatograph, gas phase, infrared, ultraviolet, total organic carbon analyzer, as well as facilities such as animal rooms (to accept thermogenic, abnormal toxicity, and
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Storage

It is equipped with normal temperature storage, shade storage, elevated storage and other facilities, with a total cargo spaces of not less than 10,000.
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Enterprise Honor
Since its inception, the company has been operating in good faith and developing in three dimensions, and has been commended by the provincial, municipal and district governments for many times, and has won a good reputation in the industry. The company is recognized as a high-tech enterprise by Jiangsu provincial government; a private technology enterprise in Jiangsu province and a technology-intensive and knowledge-intensive enterprise with foreign investment in Jiangsu province by Jiangsu provincial government; a contract-abiding and trustworthy enterprise by Jiangsu and Nanjing governments; an advanced technology enterprise with foreign investment in Nanjing by Nanjing government; and a number of its products have received provincial and municipal awards. In 2010, the company was selected as one of the top 100 pharmaceutical companies in China.
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