Founded in August 1994, Tianjin Institute of Pharmaceutical Research is situated at No.29, Huixin Road, Binhai Science and Technology Park, Binhai High-tech Zone, covering an area of over 90 mu. As a wholly-owned subsidiary of TIPR, the company launched the mixed ownership reform of state-owned enterprises in 2018, and turned into a member of the massive health sector of China Merchants Group, positioning itself as a top manufacturing enterprise of preparations. The company has passed GMP certification for small-volume injections, oral solid preparations, granules, minoxidil, buprenorphine hydrochloride, argatroban, adefovir dipivoxil, etc. as well as other API varieties, and its products are involved with cardiovascular and cerebrovascular diseases, hypoglycemic, antipyretic and anti-inflammatory, mental and nervous fields. etc. Moreover, it has been in possession of a perfect quality management system and pharmaceutical talent echelon, it is a national designated production unit of psychotropic drugs, and has been consecutively approved as a high-tech enterprise in Tianjin for many years.
Currently, this pharmaceutical company has all types of production capacities for small-volume injections, tablets, granules and active pharmaceutical ingredients, among which the workshop of small-volume injections has been provided with three production lines with a designed production capacity of 200 million units per year. At present, the principal products include: agatraban Injection (Dabei®), buprenorphine hydrochloride injection (Shafei®), ambroxol hydrochloride injection (Yinuoshu®), and the second-class psychotropic drug dezocine injection will be put into production soon. The workshop of oral solid preparations has set up a production line of tablets and granules, with a design capacity of one billion tablets (bags) per year. Now, the main products are adefovir dipivoxil tablets (Daiding®), risperidone tablets (Zhuofei®), gliquidone (Jieshi®) and buprenorphine hydrochloride sublingual tablets (Shafei®).
As an independent industrialization platform for major scientific research achievements and drug innovation achievements of TIPR, the company has undertaken six major scientific and technological projects of “Creation of Major New Drugs” in the National “Eleventh Five-Year Plan” and “Twelfth Five-Year Plan” (including two large-variety projects: “Technical Transformation of Anti-HBV Drug Adefovir Dipivoxil” and “Technical Transformation of Ambroxol Hydrochloride Injection (Yinuoshu)”; Two platform construction projects: “Pilot Technology Platform for Preparation of Chiral and Polymorphic Drugs of Kilogram Grade” and “Construction of Technology Platform for Detection and Separation of Trace Impurities in Drugs”; two patented drug projects: “Research and Development of a New Antipsychotic Drug-Iloperidone and Its Tablets”, “Industrialization of Strontium Ranelate, a New Osteoporosis Treatment Drug with Two-way Mechanism”), as well as a number of national 863 Program, Torch Program, national key scientific and technological innovation projects, etc. It has been eligible for the new drug creation in Tianjin, “Study on the Consistency Evaluation of Quality and Efficacy of Argatroban and Its Injection”, “Study on the Consistency Evaluation of Quality and Efficacy of Adefovir Dipivoxil and Its Tablets” and other projects.
Looking into the future, Tianjin Institute of Pharmaceutical Research will bring into full play to its own superiority, proactively attract and train talents, make contribution to building a world-class pharmaceutical research institute and a century-old pharmaceutical research institute, and endeavor to stride forward towards a domestic leading and international excellent pharmaceutical enterprise.
Tianjin Taipu Pharmaceutical Co., Ltd. was founded in 2010 and is a whollyowned subsidiary of Tianjin Pharmaceutical Research Institute Co., Ltd. In 2018, Tianjin Pharmaceutical Research Institute Co., Ltd.joined the health industry of China Merchants Group through the reform of state-owned enterprise mixed ownership. It is a R&D type of API manufacturer integrating technology development，independent innovation， achievement transformation and technical services.
R&D and technology platform
The company has a Prst-class API R&D center, and has successfully developed lndapamide (the Prst second-class new drug in China), Argatroban (the exclusive domestically marketed product for 10 years), Adefovir Dipivoxil (the Prst nationwide listing), Dezocine (transferred to Yangze River Pharmaceutical Group, annual sales of over 4 billion), and a batch of new products with large market, high technical difpculty and outstanding efpcacy. The company’s current research varieties cover key areas such as anticoagulation, respiratory, antiviral, neuropsychiatric, and metabolism.
The company accelerates the construction of continuous Bow technology platform and green chemistry technology platform, effectively promotes the wide application of continuous reaction, biological enzyme catalysis and other core technologies in the development and production of various projects, quickly solves the problems of process technology and engineering ampliPcation, and greatly improves reaction ef Pciency , reduce costs, truly realize green technology, and solve safety and environmental issues.
Production capacity
The company is equipped with domestically advanced API production equipment and related supporting automation system facilities, and empowers advanced digital and automated control systems in the traditional API production industry. Through real-time collection and archiving of production process data, a large number of accurate process data can realize the quality tracking of the whole process of drug production.
Quality and compliance with GMP and ICH guidelines
The company has established a quality management system in accordance with the requirements of GMP and ICH guidelines, and organized various quality activities. All requirements for safety, effectiveness and quality control are systematically implemented in the entire process of product development, production, control and product release, storage, and shipment.The company has an independent quality assurance department and quality control department, equipped with sufficient and professional QA and QC personnel to ensure the effective operation of the system and a good delivery record.
EHS management system
The company has professional EHS management capabilities. In terms of safety, the company has a safety testing laboratory, which can independently complete the safety assessment of dangerous processes, achieve the intrinsic safety of product technology from the R&D transfer stage, and realize the concept of “supporting intrinsic safety with data”. In terms of environmental protection, the company adheres to the governance concept of “clean production and green development” and becomes the Prst pharmaceutical company in Tianjin Economic-Technological Development Area to obtain a pollutant discharge permit. In occupational health management, the company uses OELjob grading, comprehensively analyzes occupational hazards in each production line and job category, and independently researches and establishes a complete API PPE system. Ensure that a complete set of closed-loop systems can be formed from the source of the hazard to the subsequent protection.
Through more than ten years of development, the company has leading R&D technology platform capabilities, perfect quality management, and EHS management system.
As a national high-tech enterprise, we will base on China and look at the world. We will rely on strong R&D strength as the cornerstone of development. Through global registration capabilities and commercialization capabilities, we will strive to build a R&D pharmaceutical enterprise integrating technology development, independent innovation, achievement transformation and technical services.
Founded in December 2019, Tianke (Jingzhou) Pharmaceutical Co., Ltd. is a large-scale API production enterprise jointly invested and built by Tianjin Institute of Pharmaceutical Research and Jingzhou Chucheng Investment Co., Ltd.
The company (phase I) covers an area of 230 acres and the products involve mental nervous system, hypertension, diabetes, liver disease, cardiovascular and cerebrovascular areas.
Adhering to the concept of “safety, health and environmental protection”, the company will build into an industrial base of API that meets the national GMP requirement, FDA standards of the European Union and the United States. The company will insist on the use of green and continuous production technologies, reconstruct a traditional API manufacturing industry with safe, environment-friendly and green production process, and explore the international market.
The company will give full play to the advantages of Tianjin Institute of Pharmaceutical Research in drug development, GMP certification and pharmaceutical intermediates, and the regional and industrial advantages of Jingzhou Development Zone, and provide high-quality API products with the medical technology.
China’s leader in high-quality professional clinical nutrition solutions
Since 2020, the company started the project with a total investment of RMB 12.226 million and built an annual production line with 300 tons of nutritious food through the purchase of vertical mixer, feeder and other equipment. The company will build an advanced automatic liquid emulsion production workshop (area: 5000m2) in 2021.
