Home>APIs>

Tranexamic Acid

CAS number: 1197-18-8

Molecular formula: C8H15NO2

molecular weight: 157.21

Chemical structure:

Producers shown on SFDA

(Record date:01/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Xi'an Libang Pharmaceutical Co., Ltd.

GMP
Valid till January 2023

Hunan Dongting Pharmaceutical Co., Ltd.

GMP, DMF, CEP
Valid till January 2021

Yantai Valiant Pharmaceutical Co., Ltd.

GMPValid till June 2024

Changzhou Yinsheng Pharmaceutical Co., Ltd.

GMP, DMF, CEP
Valid till June 2022

Hubei Zhongjiachem Pharmaceutical Co.,Ltd.

GMP

Valid till February 2020

Shanghai Xiandai Hasen(Shangqiu) Pharmaceutical Co., Ltd.

GMP
Valid till February 2024

Kaifeng Pharmaceutical (Group) Co., Ltd. 

GMP
Valid till November 2020



Producers shown on EP

(Quoted from EP website;record date:01/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Tranexamic acid
AMI LIFESCIENCES PRIVATE LIMITED IN 390 020 Vadodara
  R0-CEP 2019-250-Rev 00
28/07/2021
VALID
/Chemistry
Tranexamic acid
ASAHI KASEI FINECHEM CO., LTD. JP 530-6130 Osaka
  R1-CEP 2008-186-Rev 01
05/05/2020
VALID
/Chemistry
Tranexamic acid
CMIC CMO CO., LTD. JP 428-0013 Shimada
  R1-CEP 1998-027-Rev 03
04/03/2010
WITHDRAWN BY HOLDER
07/12/2018
Chemistry
Tranexamic acid
KYOWA PHARMA CHEMICAL CO., LTD. JP 933-8511 Takaoka
  R1-CEP 2012-271-Rev 01
30/04/2020
VALID
/Chemistry
Tranexamic acid
CHANGZHOU YINSHENG PHARMACEUTICAL CO., LTD. CN 213 003 Changzhou
  R0-CEP 2009-109-Rev 00
07/10/2011
WITHDRAWN BY HOLDER
08/07/2016
Chemistry
Tranexamic acid
Hunan Dongting Pharmaceutical Co. Ltd CN 415001 Changde
  R1-CEP 2006-142-Rev 02
27/08/2020
VALID
/Chemistry
Tranexamic acid
SHILPA MEDICARE LIMITED IN 584 135 Raichur
  R0-CEP 2018-048-Rev 00
08/08/2019
VALID
/Chemistry

Producer:Xi'an Libang Pharmaceutical Co., Ltd. was founded by returned overseas students in 1996. It is a high-tech enterprise integrating drug R & D, production and sales. The company is located in Xi'an high tech Industrial Development Zone with a registered capital of 15 million yuan.   Its three pharmaceutical factories have passed the new GMP certification; It has more than ten GMP production lines such as small volume injection, large volume injection and oral solution;   It produces more than 20 kinds of chemical synthetic APIs and more than 50 specifications of pharmaceutical preparations.

Staff size:500-599 persons

Registered capital:RMB 15 million


Producer:Hunan Dongting Pharmaceutical Co., Ltd. is a member enterprise of Shanghai Fosun Pharmaceutical Group, a domestic brand enterprise in the field of chemical hemostatic drugs and one of the world's major suppliers of API.

The company's hemostatic drugs tranexamic acid and aminotoluene acid have formed the advantages of large production and marketing scale and good quality; All products of the company have obtained the national GMP certification certificate. The quality of tranexamic acid meets the standards of USP, British Pharmacopoeia, Japan Pharmaceutical Bureau and European Pharmacopoeia, and has passed the certification of FDA, cos of EU and PMDA of Japan, and has been exported to many countries and regions.

Staff size:1000-1999 persons

Registered capital:RMB 309.65367 million 


Producer:Yantai Valiant Pharmaceutical Co., Ltd.a wholly-owned subsidiary invested by cecep Wanrun Co., Ltd., is a comprehensive pharmaceutical enterprise specializing in the development, production and sales of API, oral solid preparations and health food.

The API synthesis workshop covers an area of about 1700 square meters and a construction area of about 7200 square meters. There are three hundred kilogram production lines meeting the GMP production requirements, one kilogram production line and one gram production line, which can meet the production needs of different batches of products. In addition, there are four clean areas with grade D cleanliness to meet the needs of product refining, drying and packaging in a clean environment, and the annual production capacity of API can reach 100 tons. The company submitted the first DMF to FDA in 2010; The company has obtained the certificate of foreign manufacturer of pharmaceutical products issued by the Japanese government,

Staff size:200-299 persons

Registered capital:RMB 75 million


Producer:Changzhou Yinsheng Pharmaceutical Co., Ltd., established in April 2003 and located in Changzhou high tech Zone, is a modern pharmaceutical enterprise integrating R & D, production and sales. The overall layout of the company is built in strict accordance with the corresponding standards of GMP in China and cGMP in Europe and America. The whole plant covers an area of 33076m2, and the existing plant facilities cover an area of about 15000m2. A supporting class D fine drying car room has been built, which meets the requirements of drug production.

The company has successively passed China GMP certification, EU CEP registration, Japan MF registration, India registration, etc. the company also passed the third review of FDA in May 2016. Its products are exported to Europe, America, India, Russia, Southeast Asia and other more than 30 countries and regions.

Staff size:100-199 persons

Registered capital:RMB 20 million


Producer:Hubei Zhongjiachem Pharmaceutical Co.,Ltd. is a modern pharmaceutical enterprise integrating R & D, production and marketing of chemical APIs. The company is located in yuekou Industrial Park, Tianmen City, with a registered capital of 20 million yuan and an area of 35000 m2.

The company now produces albendazole, pinoxin sodium, propyl gallate, tranexamic acid and other APIs, of which the leading product albendazole has obtained the drug production license, drug production approval number and GMP certificate issued by the State Food and drug administration. Albendazole produced by Zhongjia pharmaceutical can meet the Pharmacopoeia standards of China, Japan, the United States, the United Kingdom, India and other countries in the world at the same time, and has strong market competitiveness.

Staff size:About 50 persons

Registered capital:RMB 20 million 


Producer:Shanghai Xiandai Hasen(Shangqiu) Pharmaceutical Co., Ltd.is a holding company invested and established by the listed company Shanghai Hyundai Pharmaceutical Co., Ltd. (stock code 600420). The major shareholder is China Pharmaceutical Group Corporation. It is a pharmaceutical enterprise built in strict accordance with the modern enterprise system and the requirements of national GMP. It is a diversified enterprise integrating drug R & D, production and sales Modern national essential drug production base. The company covers an area of more than 500 mu, has a registered capital of 83.29 million yuan, a total asset of more than 600 million yuan, and has more than 1600 employees, including more than 800 professional and technical personnel; The company has obtained 163 drug production approval products, and has GMP production lines for small volume injections, oral solid preparations (tablets, capsules, granules), APIs and other dosage forms. The annual production capacity of small volume injections is 4 billion tubes, 6 billion tablets (granules and bags) of oral solid preparations and 1200 tons of API.

Staff size:1000-1999 persons

Registered capital:RMB 83.29 million


Producer:Kaifeng Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as "Kaifeng Pharmaceutical Group") was founded in May 1949. Its predecessor is Kaifeng Pharmaceutical Factory in Henan Province, a national comprehensive large class II pharmaceutical enterprise.

The company covers an area of 400000 square meters, a construction area of 170000 square meters, and more than 3000 large and medium-sized advanced production equipment. The production equipment of the enterprise is advanced and perfect, and has fully passed GMP certification and relevant acceptance. Kaiyao group is a high-tech enterprise in Henan Province, with perfect quality assurance system and quality detection and control instruments, and reliable product quality. All kinds of products produced have been spot checked by national, provincial and municipal quality supervision departments, and the qualified rate has been 100% for 23 consecutive years. The product quality meets the standards of Chinese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia and American Pharmacopoeia. It is the first self-supporting import and export enterprise in the pharmaceutical system of Henan Province approved by the Ministry of foreign economic relations and trade.

Staff size:900-999 persons

Registered capital:RMB 204 million 568 thousand and 562


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