Medicine
1. Dual certification qualification
As an organization in Shaanxi Province that has obtained NMPA drug GLP certification and successfully completed its qualification re-examination and scope expansion in 2024, Guorui Yinuo has established a “global + domestic” dual-compliance service capability in the pharmaceutical sector. Its GLP system complies simultaneously with FDA, OECD, and NMPA standards, enabling its reports to directly meet both domestic and international regulatory requirements without the need for repeated testing. This significantly shortens the international drug registration process and reduces enterprises’ R&D application costs by more than 30%.
2. Service Areas
Our services cover the entire drug development pipeline and can undertake core studies such as safety pharmacology tests, single-dose/repeated-dose toxicity tests, reproductive toxicity tests, genotoxicity tests, and toxicokinetic studies, fully complying with the requirements of the “Good Clinical Practice for Non-Clinical Studies of Drugs.”
3. Research Experience
With a 7,500-square-meter specialized laboratory and 450 internationally advanced instruments, we can efficiently conduct non-clinical safety evaluations for high-end projects such as Class I new drugs and Class II/III medical devices. Relying on years of experience in new drug evaluation, we have successfully supported numerous Class I new drugs through preclinical evaluation and regulatory submissions, achieving a submission approval rate significantly higher than the industry average. Our wealth of practical experience provides solid support for the research, development, and commercialization of pharmaceutical products.
4. Instruments and Equipment
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AB Liquid Chromatography–Mass Spectrometry System | NAS server room | Pathological Diagnosis Microscopy System |
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Shimadzu High-Performance Liquid Chromatograph | Vertical Ultra-Low Temperature Storage Box | Hitachi Fully Automatic Biochemical Analyzer |
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SITA High Emo Express Fully Automatic Coagulometer | Siemens Fully Automatic Blood Analyzer | Atomic fluorescence spectrophotometer |
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Automated Small Animal Oral and Nasal Inhalation Exposure System |
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5. Typical Cases
Guorei Yinuo signed a contract with XX Research Co., Ltd. for “XX Injection.” Guorei Yinuo was responsible for conducting animal studies using rabbits and guinea pigs, providing technical service summary reports, and assisting XX Company in completing the non-clinical research project for XX Injection. Ultimately, on June 27, 2023, the company received approval from the Drug Review Center of the National Medical Products Administration.
On February 8, 2022, Guorui Yinuo signed a contract titled “XX Vaccine Trial Study” with XX Co., Ltd. Guorui Yinuo was responsible for conducting animal studies using rabbits and guinea pigs, providing technical service summary reports, and assisting in the non-clinical research project for the XX vaccine. Ultimately, the project received approval from the National Medical Products Administration, and the product is now on the market and undergoing mass production. The key features of this project’s services include highly efficient (the XX project was completed in 55 days, whereas, according to industry standards, such trials typically take between 120 and 180 days) and high-quality technical services for non-clinical safety evaluation of pharmaceuticals.
On April 14, 2022, Guorui Yinuo signed a contract with XX Co., Ltd. for the “XX Mutation Test (Ames),” assisting XX Co., Ltd. in completing the impurity toxicity study test mandated by the National Medical Products Administration. The test stipulated a research period of three months; however, we completed the study 20 days ahead of schedule and submitted the report to the National Medical Products Administration.
Statistical Table of Approved Information for Certain Test Substances (Source: National Medical Products Administration)
Serial number | Product Name | Specifications | Approval Number | Marketing Authorization Holder | Approval Date |
1 | Xx Hydrochloric Acid Injection | 5 ml : 25 mg | National Drug Approval Number H20000xxx | Xi'an XX Limited Liability Company | 2025-07-04 |
2 | XX Acid Injection | 5 ml : 0.25 g | Drug Approval Number H20244xxx | Yunnan XX Co., Ltd. | 2024-06-28 |
3 | xx vaccine | 0.5 ml/vial/box | National Drug Approval Number S20227xxxx | Jiangsu xxx Biotechnology Co., Ltd. | 2022-08-24 |
4 | XX Injection Solution | 4 ml: 40 mg | National Drug Approval Number H20243xxx | XX Pharmaceutical (Hebei) Co., Ltd. | 2024-06-04 |
5 | XX Alkali Injection | 2 ml: 300 mg | National Drug Approval Number H20243xxx | Sichuan XX Pharmaceutical Technology Co., Ltd. | 2024-02-23 |
6 | For injection xx | 1.0 g | Drug Approval Number H20244xxx | Guangdong XX Pharmaceutical Co., Ltd. | 2024-07-30 |
7 | XX Injection Solution | 2 mL: 20 mg | National Drug Approval Number H20253xxx | Yunnan XX Pharmaceutical Co., Ltd. | 2025-03-04 |
8 | Xx Hydrochloric Acid Injection | 5 ml: 200 mg | National Drug Approval Number H20253xxx | Shanxi XX Pharmaceutical Technology Co., Ltd. | 2025-01-14 |
9 | Xx Hydrochloric Acid Injection | 2 ml: 0.6 g (calculated as C18H34N2Q6S) | Drug Approval Number H37021xxx | Shandong XX Co., Ltd. | 2025-02-17 |
10 | XX Injection Solution | 2 ml: 20 mg | Drug Approval Number H20244xxx | Yunnan XX Pharmaceutical Co., Ltd. | 2024-08-27 |
11 | Xx Hydrochloric Acid Injection | 10 ml: 75 mg | National Drug Approval Number H20203xxx | Shandong XX Co., Ltd. | 2024-09-10 |
12 | XX Injection Solution | 4 ml: 20 mg | National Drug Approval Number H20255xxx | Jiangsu XX Technology Co., Ltd. | 2025-09-09 |
13 | For injection xx | 1.5 g | Drug Approval Number H20244xxx | Shenyang XX Co., Ltd. | 2024-08-05 |
14 | For injection xx | 1.0 g | National Drug Approval Number H20253xxx | XX (Tianjin) Innovative Pharmaceutical Research Co., Ltd. | 2025-04-15 |
15 | XX Injection Solution | 5 ml: 50 mg | National Drug Approval Number H20249xxx | XX Joint-Stock Company | December 10, 2024 |
16 | XX Injection Solution | 2 ml: 0.5 mg | National Drug Approval Number H20249xxx | Jiangsu XX Co., Ltd. | December 1, 2024 |
17 | Sulfur xx | 10 mL:5 g | National Drug Approval Number H20253xxx | Fujian XX Co., Ltd. | 2025-04-08 |
18 | XX Alkali Injection | 2 mL: 0.3 g | National Drug Approval Number H20253xxx | Fujian XX Co., Ltd. | 2025-01-02 |
19 | Xx Hydrochloric Acid Injection | 5 ml: 100 mg | Drug Approval Number H20244xxx | Nanjing XX Technology Development Co., Ltd. | 2024-09-03 |
20 | xx solution (for irrigation) | 500 ml | Drug Approval Number H20244xxx | Xi'an XX Technology Co., Ltd. | 2024-09-19 |
21 | XX Injection Solution | 10 ml: 0.1 g | National Drug Approval Number H20253xxx | Shandong XX Co., Ltd. | 2025-03-18 |
22 | XX Injection Solution | 20 ml: 3.0 g | National Drug Approval Number H20247xxx | Shandong XX Co., Ltd. | 2024-05-07 |
23 | Xx Hydrochloric Acid Injection | 10 ml: 50 mg | National Drug Approval Number H20254xxx | Nanjing XX Technology Co., Ltd. | 2025-06-03 |
24 | xx eye drops | 0.4 ml:0.4 mg | National Drug Approval Number H20249xxx | Shandong XX Co., Ltd. | 2024-10-29 |
25 | XX Alkali Injection | 2 ml: 0.3 g | National Drug Approval Number H20253xxx | Shaanxi XX Co., Ltd. | 2025-03-11 |
26 | Xx Hydrochloric Acid Injection | 5 ml: 100 mg | National Drug Approval Number H20255xxx | Tibet XX Pharmaceutical Group Co., Ltd. | 2025-07-29 |
27 | Xx Hydrochloric Acid Injection | 1 ml: 1 mg | National Drug Approval Number H33021xxx | Hangzhou XX Co., Ltd. | 2024-06-05 |
28 | Benzenesulfonate XX | 5 ml: 10 mg | Drug Approval Number H20163xxx | / | 2023-11-22 |
29 | Xx Hydrochloric Acid Injection | 20 ml: 250 mg | National Drug Approval Number H20249xxx | Shaanxi XX Co., Ltd. | December 1, 2024 |
30 | Xx Hydrochloric Acid Injection | 10 ml: 0.1 g | National Drug Approval Number H20067xxx | Shandong XX Limited Liability Company | 2023-10-17 |
31 | XX Injectable Solution | 1 ml: 100 μg | National Drug Approval Number H20256xxx | Yunnan XX Pharmaceutical Co., Ltd. | December 9, 2025 |
32 | Xx Hydrochloric Acid Injection | 2 ml: 4 mg | National Drug Approval Number H20255xxx | Yunnan XX Pharmaceutical Co., Ltd. | November 12, 2025 |
33 | XX Injection Solution | 50 ml: 10 mg | National Drug Approval Number H20064xxx | Jiangsu XX Co., Ltd. | 2025-06-24 |
34 | XX Injection Solution | 2 ml: 0.3 g | National Drug Approval Number H20254xxx | Wuhan XX Technology Co., Ltd. | 2025-05-13 |
35 | XX Injection Solution | 10 ml: 1 g | National Drug Approval Number H20253xxx | Suzhou XX Pharmaceutical Co., Ltd. | 2025-04-15 |
36 | xx topical lotion | 5% (60 ml: 3.0 g) | National Drug Approval Number H20255xxx | Shandong XX Co., Ltd. | 2025-08-19 |
37 | Calcium Gluconate Injection | 10 ml: 1 g | National Drug Approval Number H20233xxx | Zhejiang XX Co., Ltd. | 2023-08-29 |
38 | Xx Hydrochloric Acid Injection | 2 ml: 10 mg | National Drug Approval Number H20255xxx | Sichuan XX Technology Co., Ltd. | 2025-09-09 |
39 | For injection xx | 1.0 g | National Drug Approval Number H20258xxx | Shanghai XX Pharmaceutical Co., Ltd. | October 31, 2025 |
40 | XX Injection Solution | 2 ml: 10 mg | National Drug Approval Number H20254xxx | Shaanxi XX Pharmaceutical Co., Ltd. | 2025-06-03 |
41 | xx eye drops | 3% (5 ml: 150 mg) | National Drug Approval Number H20253xxx | Chongqing XX Pharmaceutical Technology Co., Ltd. | 2025-04-08 |
42 | xx eye drops | 0.2% (5 ml: 10 mg) | National Drug Approval Number H20253xxx | Shijiazhuang XX Pharmaceutical Co., Ltd. | 2025-03-25 |
43 | xx eye drops | 5 ml | National Drug Approval Number H20254xxx | Shijiazhuang XX Pharmaceutical Co., Ltd. | 2025-05-13 |
44 | For injection xx | 0.25 mg (calculated as C₇₀H₉₂ClN₁₇O₁₄) | National Drug Approval Number H20255xxx | XX Pharmaceutical Co., Ltd. | October 14, 2025 |
45 | XX Injection Solution | 2 mL: 20 mg | National Drug Approval Number H20255xxx | Beijing XX Pharmaceutical Technology Co., Ltd. | 2025-09-16 |
46 | For injection xx | 0.5 g | National Drug Approval Number H20254xxx | Hefei XX Co., Ltd. | 2025-05-27 |
47 | XX Injection Solution | 2 ml: 0.2 g | National Drug Approval Number H20254xxx | Shanxi XX Pharmaceutical Technology Co., Ltd. | 2025-07-29 |
48 | XX Injection Solution | 20 mL: 2.98 g | National Drug Approval Number H20247xxx | XX Joint-Stock Company | 2024-12-05 |
49 | Xx Adrenalin Injection | 4 ml: 8 mg | National Drug Approval Number H20254xxx | Jiangsu XX Co., Ltd. | April 30, 2025 |
50 | xx solution (for irrigation) | 500 ml | National Drug Approval Number H20254xxx | Hainan XX Co., Ltd. | 2025-07-22 |
51 | XX Injection Solution | 2 ml: 10 mg | National Drug Approval Number H44022xxx | Guangdong XX Pharmaceutical Co., Ltd. | 2024-09-06 |
52 | Xx Hydrochloric Acid Injection | Calculated based on C₁₈H₂₃NO₃: 2 ml : 20 mg | National Drug Approval Number H44022xxx | Guangdong XX Pharmaceutical Co., Ltd. | October 10, 2024 |
53 | Xx Hydrochloric Acid Injection | 2 ml: 50 mg | National Drug Approval Number H41021xxx | XX Joint-Stock Company | 2024-08-14 |
54 | XX Injection Solution | 2 ml: 0.2 mg | National Drug Approval Number H44024xxx | Guangdong XX Co., Ltd. | November 28, 2024 |
55 | XX Injection Solution | 1 ml: 5 mg | National Drug Approval Number H41020xxx | Zhengzhou XX Co., Ltd. | 2024-05-07 |
More fields
As an institution in Shaanxi Province that has obtained NMPA drug GLP certification and completed its qualification re-examination and scope expansion in 2024, Guorui Yinuo has built a “global + domestic” dual-compliance service capability in the pharmaceutical sector.
The one-stop service platform for veterinary drugs—GLP/GCP—is a specialized service provider that offers an integrated solution—from non-clinical evaluation to clinical trials and registration submission—aligned with both the Ministry of Agriculture and Rural Affairs’ GLP/GCP standards for veterinary drugs and the international OECD GLP standards, covering the entire R&D process for veterinary pharmaceuticals. At its core, this platform addresses the key pain points faced by companies, including long R&D cycles, high compliance barriers, and fragmented resources.
As the only organization in the Northwest region to have obtained OECD GLP certification in the pesticide field, Guorui Yinuo passed the international assessment with a zero-defect record. Relying on its compliance credentials, comprehensive technological capabilities across the entire value chain, and high-standard laboratory platform, Guorui Yinuo provides integrated solutions for global pesticide companies—from research and development all the way through registration.
Relying on the OECD GLP zero-defect certification qualification, chemical test data can be globally recognized and simultaneously comply with both domestic and international chemical regulatory requirements as well as relevant requirements of the Ministry of Ecology and Environment, efficiently supporting needs such as chemical registration and export declarations.
Shaanxi Guorui Xinchuang Medical Technology Co., Ltd. is an independent, third-party clinical preclinical safety evaluation research institution for medical devices. It was registered and established in June 2020 in the Airport New City and is currently the most comprehensive medical device safety evaluation institution in Northwest China. The company primarily provides product safety evaluation services to R&D enterprises specializing in Class II and Class III medical devices.
A full-process technology empowerment platform from target discovery to IND submission
Early Toxicity Prediction and Screening
Early toxicity screening is an essential and indispensable step in the new drug development process. Early termination of compounds that show no development potential can save sponsor substantial amounts of manpower, resources, and time. We offer sponsor comprehensive early toxicity screening services, including early genotoxicity assessment, early general toxicity assessment, and early reproductive and developmental toxicity assessment.
We are equipped with specialized instruments and devices, including flow cytometers, microplate readers, fluorescence microscopes, and PCR machines. These resources enable us to establish animal models for diseases affecting the tumor, cardiovascular, respiratory, metabolic, and urinary systems, and to conduct comprehensive and systematic preclinical studies on drug efficacy and mechanisms at multiple levels.









