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L-Lysine Acetate

CAS number: 52315-76-1

Molecular formula: C8H18N2O4

molecular weight: 206.2395

Chemical structure:

Producers shown on SFDA

(Record date:17/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Shantou Jiahe Biological Technology Co., Ltd.

GMP
Valid till September 2024

Yichang Sanxia Pharmaceutical Co., Ltd.

GMP
Valid till December 2020

Yichang Sanxia Proudin Biopharmaceutical Co., Ltd.

GMP
Valid till November 2022

Shantou Unisplendour Guhan Amino Acid Co., Ltd.

GMP

/

Hubei Bafeng Pharmaceutical Chemical Co., Ltd. 

GMP
Valid till December 2020

Wuxi Jinghai Amino Acid Co.,Ltd.

GMP
Valid till October 2022

Bengbu BBCA Tushan Pharmaceutical Co.,Ltd.

GMP
Valid till June 2019

Tianjin Tianyao Pharmaceutical Co., Ltd.

GMP

Valid till January 2020


Producers shown on EP

(Quoted from EP website;record date:17/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Lysine acetate
Ajinomoto Co., Inc. JP 104-8315 Tokyo
  R1-CEP 2005-060-Rev 01
12/02/2015
VALID
/Chemistry
Lysine acetate
KYOWA HAKKO BIO CO., LTD. JP 100-8185 Tokyo
  R1-CEP 2014-227-Rev 00
21/01/2021
VALID
/Chemistry
Lysine acetate NC
Ajinomoto Co., Inc. JP 104-8315 Tokyo
  R1-CEP 2014-063-Rev 00
14/10/2020
VALID
/Chemistry
Lysine acetate
EVONIK REXIM S.A.S. FR 80400 Ham
  R1-CEP 2010-155-Rev 01
15/02/2019
VALID
/Chemistry
Lysine acetate
AMINO GMBH DE 38373 Frellstedt
  R0-CEP 2016-042-Rev 00
30/03/2017
VALID
/Chemistry

Producer:Jiahe biology is a high-tech enterprise dedicated to the R & D, production and sales of amino acids and their derivatives. Shantou Jiahe Biological Technology Co., Ltd. is one of the main production bases of amino acid API in China, with drug production license, several GMP production workshops and multiple production lines of various amino acid products.
Staff size:100-199 persons

Registered capital:RMB 50 million


Producer:Yichang Sanxia Pharmaceutical Co., Ltd.is a wholly-owned subsidiary of humanwell Pharmaceutical Group. The company is a national high-tech enterprise. It is a comprehensive biopharmaceutical enterprise that studies and produces antibiotic API, amino acid series high-capacity injections and animal drug preparations.

The company is a large global supplier of neomycin sulfate API. Its subdivided product line covers neomycin sulfate for animals, Fraxinus sulfate, neomycin sulfate for prescription people in the United States, etc. its products have passed the certification of FDA and CEP of the European Union, with a global market share of more than 80%. Neomycin sulfate has won the title of "single champion product" in the national manufacturing industry. The company is also one of the earliest manufacturers of amino acid high-volume injections in China. At present, it mainly produces compound amino acid infusion and other basic infusion with product specifications of 3AA, 6Aa, 9aa, 15aa, 17aa, 17aa-i and 18AA, and the product specifications of various soft bags and glass bottles have reached 46. Among them, "Three Gorges brand" series amino acid high-volume injections are recognized as "famous brand products" and "high-quality products" in Hubei Province. The sales volume of compound amino acid injection 3AA accounts for more than 50% in China.

Staff size:1000-1999 persons

Registered capital:RMB 390 million


Producer:Yichang Sanxia Proudin Biopharmaceutical Co., Ltd.is a supplier committed to R & D and production of high-end amino acid series raw materials and preparations. The company's quality system is perfect. It has successively passed the GMP certification, HACCP quality management system certification, kosher and Halal certification of the State Food and drug administration. It is applying for the European Pharmacopoeia certificate. It is one of the drafting and formulation units of national drug standards for many amino acid products.

Staff size:200-299 persons

Registered capital:RMB 350 million


Producer:Shantou Unisplendour Guhan Amino Acid Co., Ltd., founded in 1958, formerly known as Shantou Hongwei amino acid factory, is now the production base of Xilong chemical pharmaceutical API and one of the main production bases of amino acid API in China. The company has a plant of 25100 square meters, is committed to the R & D and production of amino acid series products, and has obtained the production approval number of 10 kinds of amino acid API and medicinal glycerol.
Staff size:About 50 persons

Registered capital:RMB 7.2941 million


Producer:Hubei Bafeng Pharmaceutical Chemical Co., Ltd. was established in 1997. The company has GMP certificate and more than 20 drug approval numbers. It has an annual production capacity of 3000 tons of amino acid API, 20 million pieces of amino acid oral liquid and 750 million pieces (tablets and bags) of amino acid preparations.
Staff size:200-299 persons

Registered capital:RMB 30 million


Producer:Wuxi Jinghai Amino Acid Co.,Ltd., founded in 1995, is one of the largest amino acid manufacturers in China, mainly producing various injection grade, pharmaceutical grade and amino acid products.

It has formed a supporting production capacity of dozens of series amino acids, with an annual output of more than 3000 tons. The company has passed GMP certification, ISO9001, ISO22000, kosher, halal, FDA and other international certifications.

Staff size:200-299 persons

Registered capital:RMB 12 million


Producer:Bengbu BBCA Tushan Pharmaceutical Co.,Ltd.is the core backbone enterprise of Anhui Fengyuan Pharmaceutical Co., Ltd., and 24 production lines have passed the GMP certification.

Staff size:400-499 persons
Registered capital:RMB 88 million


Producer:Tianjin Tianyao Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Tianjin Jinyao Group Co., Ltd., is the first API production unit in Tianjin that has all passed the national GMP certification. It is the largest scientific research, production and export base of steroid corticosteroids in Asia. The company mainly produces more than 40 varieties of corticosteroid raw materials, cardiovascular and cerebrovascular raw materials, analgesic raw materials and preparation drugs, of which many products have passed the certification of FDA and European Pharmacopoeia Committee, and become a qualified supplier of Pfizer and other large multinational companies. The company's leading product dexamethasone (corticosteroid drugs) series technology and product quality have reached the international advanced level. Taking advantage of low cost and service advantages, the company has occupied the Asian market of dexamethasone and opened the European and American markets; The company's annual production capacity of corticosteroid APIs has reached more than 200 tons.
Staff size:About 3000 persons

Registered capital:RMB 1 billion 101 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +8618402846978