Service Units Introduction
 
R&D Building Inside
Staff
Most of the synthesis researchers are senior chemists and high-qualified college graduates, engaged in process R&D and industrial scale-up for APIs and intermediates. The professional and excellent works they have achieved help CPRI enjoy a good fame for medicinal chemistry in this country.
Lab
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Space: 13, 000 sq. ft. occupying two floors
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12 standard labs with Central vacuum for different functions
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Dedicated warehouse and storage rooms
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Separate Hydrogenations room
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Separate scale-up room with Walk-in fume hood
Facilities
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LTC Liquid circulating pumps
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Preparation HPLCs
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Autoclaves, different scale
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1ml to 20L Reactors
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Ultra low temperature Reactor
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2 to 20L Scale Rotary Evaporators
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Conventional equipment and tools
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Associated addition and work up equipment
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Scale-up workshop, up to 500L Reactors
Capabilities
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Multi-step reaction schemes
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-80¡æ - 300¡æreactions
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Moisture-free or Oxygen-free operation
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Sample Separation and purification
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Hydrogenation reaction and high pressure reaction
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Scale-up process study
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General reaction in synthesis labs
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Chiral technologies, 20+ chiral drug have been developed successfully in recent 5 years
Services provided
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Process development & optimization for API and Intermediates.
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Laboratory-size and industrial-size process scale-up
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Small-volume samples for preclinical study and clinical trial (GMP)
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Reference standards
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Impurity standards
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Novel route design
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Literature synthesis
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R&D for Chiral drugs
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Novel compound synthesis
The most advanced equipment and high-qualified talent are enriched in this sector.
Facilities
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LC/MS/MS (Agilent)
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HPLCs (VWD, DAD, ELSD, RID; Headspace, Autosampler, Agilent or )
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GC (FID, TCD; Headspace, Autosampler, Agilent)
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FT-IR
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UV
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Karl Fisher Titrator
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Auto Potential Titration
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M.P. test meter
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Osmometer
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Polarograph
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Particle Size Analyzer
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Stability chambers
Services
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CPRI offers diversified pharmaceutical analysis services including:
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Analytical method development/Validation for API and finished product
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Drug substance and drug product characterization: Isolation, Purification, Structural Elucidation, Purity Characterization, Physical-Chemical Properties
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Identification of impurities
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Specification and Quality control development
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Residue depletion studies
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Stability studies
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Chiral substances separation and analysis
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Bioanalysis for biological Samples
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Test service for Chemicals and intermediates
Stability Study
Our range of storage and testing capabilities are comprehensive in scope and fully compliant with ICH guidelines, we provide stability test for APIs, Finished products, R&D preliminary stability (protocol development, testing, evaluations), Setting of specifications.
The research team consists of first-class formulation-study experts and senior researchers in china. So far they have finished 30+ projects for our customer, 3 are for international customers and have filed for 30 Chinese patents or PCT.
Scope
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Dosage form development, including tablet/capsule, injection, lyphilization, liquids, control-release tablet, semi-solids, ointment, gel, patch, nasal sprayer, inhalant.
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Development and preparation of preclinical study dosage forms.
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Support formulation scale-up, process validation.
Process study facilities
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Lyophilizer (Kg Scale)
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Rotary tablet presses (Kg Scale)
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Multi-functional fluidized bed coating (Kg Scale)
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Spray dryer (Kg Scale)
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HLSH2-6 wet granulator (Kg Scale)
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HP coating machine (Kg Scale)
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3 dissolution meters
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Equipment for transdermal study
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A lab-size GMP workshop (100 and 100,000 grade)
Clinical research management and Regulatory Support
We have a professional team engaged in managing Clinical research for many years and directly led by the deputy General manager of the company. From 1990, they have completed over 40 Clinical research projects for more than 30 customers, including a clinical BE Study for WHO which has passed the WHO experts inspection.
Besides, the professional staff has plentiful experience and deep insight in regulatory Affairs in China, and has finished 200+ Drug Application at SFDA. With their expertise in regulatory Affairs, we can help you exploring Chinese market for your new products as efficiently and cost-effectively as possible.
Clinical research management
We have established a good management system and sound SOP in our management practice of clinical research. Competent project managers and CRAs in different specialized therapeutic areas are all well-trained and experienced. All practices are conducted in strict compliance with ICH guidelines.
According to GCP requirement, as well as different requirement of the customers, we offer full range of customized services (Full clinical development phase I ¨C IV projects, from strategic planning and protocol writing to final study report).
Special in-house knowledge of the following therapeutic areas and development research activities:
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CNS (Neurology and Psychiatry)
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Cardiovascular (Indications: hypertension, congestive heart failure)
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Rheumatology (Indications: osteoid and rheumatoid arthritis)
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Anti - platelet drugs (Indications: PTCA, acute coronary syndrome, stroke)
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Respiratory (Asthma, inhalative devices)
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Oncology (Biological response modifiers, supportive therapy to chemotherapy)
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Immunology (allergy, atopical dermatitis)
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Topical formulations (Including nasal sprays, eye-drops, transdermal application systems)
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Genitourinary
Clinical trial bases
We have established close relationships with many academic centers and investigators in each therapeutic area, to facilitate patients¡¯ recruitment and accelerate study start-up. So far, we have collaborated with almost 70 hospitals to conduct clinical trials.
¡ñ Part of the Clinical bases cooperating with us
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Shanghai Ruijin Hospital Group |
Peking Union Medical College Hospital |
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Guangzhou Southern Hospital |
Shanghai Changzheng Hospital |
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Nanjin Brain Hospital |
Guangzhou Brain Hospital |
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Chongqing Southwest Hospital |
Shanghai changhai Hospital |
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Shanghai Renji Hospital |
Shanghai Zhongshan Hospital |
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Shanghai Huashan Hospital |
Affiliated Hospitals of WestChina Medical University |
Range of services
The experienced staff in our Pharmacology and Toxicology center has completed a lot of work on preclinical research of new drugs. A series of experimental animal models have been established by them to determining the pharmacological and toxical characters of diversified therapeutic use substances. They will offer you assured Discovery Support for your development practice of new products under strict confidential agreement. The range of services offered includes:
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Comprehensive primary screening
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Secondary screening
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Safety pharmacology
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Acute toxicity study
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Chronic toxicity study
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Pharmacokinetics studies on animal
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Large battery of tests available
Expertise
Our know-how and experience covers all the main fields of investigation: CNS, cardiovascular, respiratory, inflammation, diuresis, gastrointestinal tract, haematology, endocrinology, hepatitis, analgesia, Rheumatology, antibiotics, etc.
The expertise lies in the following specific therapeutic areas:
Commitment
We treat experiment animals in strict compliance with international animal ethics practice.
Team working
Many of our employees have worked in CPRI for decades of years; they treat the company as their family, and willingly share their experiences and knowledge with others.
Experiences
50 yeas involved in drug development and research in China, have developed deep insight and fine tradition in this field with enriched experiences. We will be your preferred partner to explore Chinese market for your innovative new drugs.
Efficiency and Cost-Effectiveness
Firstly, we are located in southwest china, an area with abundant natural and human resources, the cost of R&D activities here are significantly lower. Secondly, we work as a whole team, people here work for common goals, and the resources in our company are managed centralized in the whole plan of the company level, which makes our R&D practices comparatively much efficient. We¡¯ll try our best to achieve 100% customer satisfaction.
High sense of responsibility
We commit ourselves to the highest standards of ethics and integrity. In china, we have been recognized with our honesty and loyalty to our clients and partners. Our R&D activities are going under fully aware of confidentiality and IP protection, providing you assured research services.
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Tel:8623-62513495
62505976 Fax:8623-62512066