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Amikacin

CAS number: 37517-28-5

Molecular formula: C22H43N5O13

molecular weight: 585.6

Chemical structure:

Producers shown on SFDA

(Record date:25/08/2021)

Producer
Documents
GMP Valid till(based on SFDA)
Chengdu Brilliant Pharmaceutical Co., Ltd. 
GMPValid till June 2020
Zhejiang Jinhua CONBA Bio-pharm. Co., Ltd.
GMPValid till February 2023
Qilu Tianhe Pharmaceutical Co., Ltd.
GMP, DMFValid till May 2023
Zhejiang Yongning Pharmaceutical Co., Ltd.
GMPValid till April 2020

Producers shown on EP

(Quoted from EP website;record date:25/08/2021)

Substance
Certificate Holder
Certificate Number
Issue
Date

Status
End date
Type
Amikacin sulfate
SHANDONG ANXIN PHARMACEUTICAL CO., LTD. CN 250 105 Dongjia Town
R1-CEP 2010-308-Rev 01
16/01/2020
VALID
/Chemistry

Producer:Chengdu Brilliant Pharmaceutical Co., Ltd. is a high-tech enterprise specializing in the R & D, production and sales of high-end generic drugs, innovative drugs, Chinese patent medicines and API.

After years of innovation and development, Brilliant Pharmaceuticals has more than 10 branches (subsidiaries) and more than 4500 employees. It has gradually developed into an innovative pharmaceutical enterprise group with advanced R & D concept, strong R & D strength, complete product pipeline, excellent production quality and sound marketing network.

Staff size:About 4500 persons

Registered capital:RMB 45 million


Producer:Zhejiang Jinhua CONBA Bio-pharm. Co., Ltd. (JINHUA CONBA) is a major subsidiary company of CONBA group, which headquarters in Hangzhou. CONBA group have more than twenty subsidiary companies.

Founded in 1958, Jinhua CONBA is located in Jinhua Pharmaceutical Industry zone, covering 85400 square meters, which takes three and a half hours to Shanghai and two hours to Hangzhou by car. It possesses total assets of RMB 500 million and the turn over in 2011 is RMB 560 million. It has more than 1000 employees, over 40% of which are technicians.
JINHUA CONBA produces both finished products and APIs including Lyophilized Powder for Injection, Capsules, Tablets and Antibiotics, Semi-sythetic antibiotics and Chemical synthetic bulk drugs. JINHUA CONBA is continually improving its quality management system and approved by European cGMP, U.S.A FDA , ISO9001, ISO14001 and Chinese GMP. It has a sales network which covers 50 major cities in China and our products are widely exported to Europe,South America and Asia.

Staff size:900-999 persons

Registered capital:RMB 520 million


Producer:Qilu Tianhe Huishi Pharmaceutical Co., Ltd., established in 2006, has developed into a national high-tech enterprise integrating the production of API and its preparations, scientific research, pharmaceutical R & D outsourcing and other businesses. The company has advanced amikacin production workshop and tazobactam production workshop, advanced anti-tumor chemical synthesis production base, and aseptic lyophilization workshop group with advanced technology and large lyophilization scale. All products of the company have passed the new national GMP certification, and the main products have passed FDA, MHRA, TGA, PMDA, EDQM, who and German GMP certification.

It has been renamed Shandong Anxin Pharmaceutical Co., Ltd

Staff size:About 2000 persons

Registered capital:RMB 1458.575 million


Producer:Zhejiang Yongning Pharmaceutical Co., Ltd., located in Taizhou, Zhejiang Province, is a pharmaceutical enterprise focusing on R & D and production of innovative drugs and preparations.
Founded in 1974, the company is the first industrial enterprise in Taizhou with annual sales of more than 100 million yuan. In 2007, it was restructured into a joint-stock enterprise with registered capital of 161.6319 million yuan and warehousing tax of more than 100 million yuan. It is a "large taxpayer in Zhejiang Province", covering an area of 140000 square meters. It has more than 1300 employees, including 50 masters, 6 doctors, more than 300 professional technicians and 23 senior titles, It has more than 100 product varieties in 5 categories, including chemical agents, chemical pharmaceutical intermediates, APIs, Chinese patent medicines and health products.
The company has fully passed the new national GMP certification, and some products have passed the certification of FDA of the United States, PMDA of Japan and KFDA of Korea.

Staff size:About 1300 persons

Registered capital:RMB 153.125 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978