Chengdu shengnuo biopharmaceutical Co., Ltd
Certificate No.: Chuan 20160288
Date of issue: January 1, 2016
Valid until: December 31, 2020
Company name: Chengdu shengnuo biopharmaceutical Co., Ltd
Legal representative: Wen Yongjun
Person in charge of the enterprise: Lu Changliang
Type of enterprise: limited liability company (Sino foreign joint venture)
Registered address: Section 1, Industrial Avenue, Dayi County, Chengdu City
Production address: Section 1, Industrial Avenue, Dayi County, Chengdu City: small volume injection (non final sterilization), granules, hard capsules, tablets, freeze-dried powder injection, API***
Production scope: the first section of Industrial Avenue, Dayi County, Chengdu City: tablets, freeze-dried powder injection, raw materials (levosimendan, thymosin, enfoviride, thymopentin, octreotide acetate, somatostatin, terlipressin acetate, atosiban acetate, entecavir, bevaludine, exenatide, zikonotide, nesiritide, carbetoxin, efebart, liraglutide) Grantirel, ganerik, desmopressin acetate, triptorelin, leuprorelin, goserelin, oxytocin, glucagon), granules, small volume injections (not final sterilization), hard capsules***
Issued by: Sichuan food and Drug Administration
Regulatory body: Dayi County market supervision and Administration Bureau
Company profile
Chengdu Shengnuo Technology Development Co., Ltd., established in July 2001, is located in Dayi County, Chengdu City, with a registered capital of 50 million yuan. Its wholly-owned subsidiaries include Chengdu shengnuo biopharmaceutical Co., Ltd., Chengdu Shengnuo Chemical Co., Ltd., and Chengdu shengnuo import and Export Co., Ltd.
From the initial registered capital of 1 million, to the current total assets of 150 million, the company has achieved sound and rapid development. With Chengdu municipal “Chengdu peptide drug engineering technology research center”, we have passed the U.S. FDA certification with 0 defects, and has become the first-class domestic peptide medicine industrial park with professional peptide drugs and product development, technology transfer, technical service, large-scale production and export.
The company has participated in the national 11th five year plan major new drug creation project “Research on key technology of peptide chemical modification and industrial scale preparation”.
The project of “new anti heart failure drug nesiritide” funded by the national science and technology small and medium-sized enterprise technology innovation fund has entered the stage of clinical research. In 2010, the company obtained the special fund support from Sichuan Provincial Economic Commission for emerging industries to produce peptide drugs The above projects have completed the project construction content. It has more than 50 key technologies for large-scale production of polypeptide drugs and products that have been listed at home and abroad, and the single batch output can reach kg level;
It has advanced international technologies, such as large-scale production technology of thiocyclic peptide, large-scale production technology of carbon cyclic peptide, complex peptide technology, rapid peptide synthesis technology, etc.; it has applied for 23 invention patents; it has obtained 5 invention patents, and has become the leader of domestic polypeptide industry with its excellent key technology of peptide synthesis and modification.
Mr. Wen Yongjun, the founder of the company, is the originator of the first polypeptide drug on the market in China, namely thymopentin (heri) of Hainan Zhonghe and thymosin α 1 with single product sales revenue of more than 500 million, and the leader of stable peptide drug R & D and production team.
The company pays attention to the combination of learning and research, and has formed a close strategic partnership with Sichuan University, Lanzhou University, Jilin University, Academy of Military Sciences, organic Institute of Chinese Academy of Sciences, and Provincial Institute of drug control.
It has successfully realized the industrialization transformation of multiple class I polypeptide new drugs for Chengdu Di’ao, Zhejiang Haizheng, Harbin pharmaceutical, Hainan Zhonghe, etc.
The company cooperates closely with foreign pharmaceutical polypeptide industry, cooperates with a polypeptide production enterprise in India, trains and guides the staff of Indian factory, and uses the company’s own technology;
keeps in touch and exchanges with international well-known peptide technology research units, studies the structure and function of biotechnological drugs from multiple angles and in-depth, so as to further apply in the field The actual accumulation of scientific data, lay a solid foundation.
With the support of governments at all levels, after years of efforts, SINOSURE has the conditions for peptide drug research and industrialization, and will strive to become the largest peptide drug production base in China.
Drug approval
| 1 | Atrosiban acetate injection | Guoyao ZhunziH20184094 | 5ml: 37.5mg (calculated by atosiban) |
|---|---|---|---|
| 2 | Somatostatin for Injection | Guoyao ZhunziH20183247 | 0.25mg |
| 3 | Somatostatin for Injection | Guoyao ZhunziH20183248 | 0.75mg |
| 4 | Somatostatin for Injection | Guoyao ZhunziH20183249 | 3mg |
| 5 | Atosiban Acetate | Guoyao ZhunziH20170007 | —- |
| 6 | Atosiban acetate injection | Guoyao ZhunziH20173256 | 0.9ml: 6.75mg (calculated by atosiban) |
| 7 | Carbetocin injection | Guoyao ZhunziH20163001 | 1ml:100ug |
| 8 | Carbetocin | Guoyao ZhunziH20163002 | 250g |
| 9 | Octreotide Acetate | Guoyao ZhunziH20153158 | 250g |
| 10 | Octreotide Acetate Injection | Guoyao ZhunziH20153159 | 1ml:0.1mg |
| 11 | Octreotide Acetate Injection | Guoyao ZhunziH20153160 | 1ml: 0.3mg (calculated by c49h66n10o10s2) |
| 12 | Enfuvirtide for injection | Guoyao ZhunziH20143159 | 90mg (calculated by enfoviride) |
| 13 | Enfuvirtide | Guoyao ZhunziH20140062 | —- |
| 14 | Thymopentin for injection | Guoyao ZhunziH20143112 | 1.6mg |
| 15 | Thymosin alpha1 | Guoyao ZhunziH20143068 | 250g |
| 16 | Thymopentin for Injection | Guoyao ZhunziH20093226 | 1mg |
| 17 | Levosimendan | Guoyao ZhunziH20110106 | —- |
| 18 | Levosimendan Injection | Guoyao ZhunziH20110104 | 5ml:12.5mg |
| 19 | Somatostatin | Guoyao ZhunziH20093270 | —- |
| 20 | Trimetazidine | Guoyao ZhunziH20073947 | —- |
| 21 | Thymopentin for Injection | Guoyao ZhunziH20074041 | —- |
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Shengnuo Biotechnology is a high-tech China polypeptide manufacturers,who has over 19 years experience for the biotechnology .Our Products involve peptide raw materials,polypeptide drug.
Our 0 defect has passed the FDA certification, and has become the first-class professional polypeptide drug and product development and large-scale production and export industry in China .
Our service scope：peptide synthesis、peptide hormones、peptide medicine、beauty peptide、peptide medicine product、peptide technology transfer、peptide technology service、peptide large-scale production、export of peptide
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