Ambroxol Hydrochloride

Producers shown on SFDA

(Record date:30/09/2021）

Producers shown on EP

(Quoted from EP website；record date:30/09/2021）

Producer:Yangzhou Sanyao Pharmaceutical Co., Ltd. covers an area of 190000 square meters and a construction area of 85000 square meters. It produces 13 dosage forms, including suspension, tablet, capsule, granule, mixture, oral solution, syrup, API and eye drops, with a total of more than 90 varieties. All dosage forms have passed the GMP certification of the State Food and Drug Administration and obtained the GMP certificate.

Staff size:300-399 persons
Registered capital:RMB 7 million 796 thousand and 697

Producer:Shaanxi Hanjiang Pharmaceutical Group Co., Ltd. currently has four API production workshops and two pharmaceutical intermediate workshops that meet GMP specifications. In recent years, the company has successively passed the new GMP audit of CFDA, the GMP audit of the Ministry of agriculture of the people's Republic of China, the FDA of the United States, the EDQM of the European Union (EU) and the official GMP audit of Mexico. All raw materials have obtained the written GMP confirmation letter for export to the EU issued by China CFDA. In terms of quality management and EHS, the company has successively passed the certification of ISO9001, ISO14001 and OHSMS18001 systems.

Staff size:600-699 persons

Registered capital:RMB139 million

Producer:Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Luoxin Pharmaceutical Group Co., Ltd.

Luoxin Pharmaceutical Group Co., Ltd. is a large pharmaceutical enterprise group integrating drug R & D, production, trade and medical and health services.

At present, the company has four manufacturing bases, including more than 50 production lines, including powder injection, lyophilized powder injection, solid preparation (including cephalosporins), spray, aerosol, pre encapsulation, large capacity injections, small volume injections, chemical raw materials, cephalosporins, and so on. There are more than ten dosage forms and more than 300 product specifications on the market. There are 48 national new drugs. The company can produce 1 billion powder injections, 500 million freeze-dried powder injections, 400 million large bottles of injections (bags), 500 million small volume injections, 7 billion tablets, 2 billion capsules, 300 million capsules, 80 million dry suspensions, 300 tons of micro pills, 1000 tons of raw materials, 30 million aerosol cans, spray ingredients, and pre encapsulated branches.
Staff size:RMB 50 million

Registered capital:700-799 persons

Producer:CSPC Ouyi Pharmaceutical Co., Ltd. is a listed enterprise under CSPC Pharmaceutical Group Co., Ltd.

The company has four pharmaceutical preparation production buildings designed according to GMP standards and four API production lines with international advanced level. The product dosage forms include small volume injection, powder injection, freeze-dried powder injection, tablet, hard capsule, soft capsule, granule, dry suspension, etc. The annual production capacity is: 9 billion tablets, 400 million hard capsules, 400 million soft capsules, 600 million bags of granules, 600 million small volume injections, 300 million powder injections and 200 million bags of dry suspensions. The product quality meets BP, USP, JP and EP standards respectively according to different requirements of customers. The company has passed the national GMP quality certification, "zero defect item" has passed the FDA certification of the United States, has also passed the MCC quality certification of South Africa, and many varieties have obtained the EU CEP certificate.

Staff size:4000-4999 persons

Registered capital:RMB 300 million

Producer:Changzhou Siyao Pharmaceutical Co., Ltd. has passed the three management system certification of national drug GMP, international environmental management ISO14001 and international occupational health and safety OHSMS18001, and three products have passed the certification of FDA and CEP of the European Union.

Current production capacity: 25 raw material intermediates, 100 tons, of which 50 tons are self exported; 20 million lyophilized powder needles and 100 million water needles; 2 billion capsules, tablets and controlled and sustained release preparations; 20 million creams and new transdermal patches.

Staff size:400-499 persons

Registered capital:USD 7.08 million

Producer:Jiangsu Hengrui Medicine Co.,Ltd. is a pharmaceutical company engaged in the development and commercialization of innovative and high-quality drugs. 

The company has 28000 employees globally, fifth R & D centers were built around the globe and several subsidiaries were established in the US, EU, and Japan.

The company has 10 manufacturing facilities and most of them maintain USP, EUP, and JP. We are the first Chinese company that exported injections on a large scale to the US, EU, and Japan markets. All dosage forms of the company have passed the national GMP certification, and ifosfamide, etoposide, mesilar and tiotepa have passed the verification of FDA.

Staff size:About 30000 persons

Registered capital:RMB 6 billion 397 million

Producer:CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.is a joint venture invested and established by CSPC Pharmaceutical Group Co., Ltd. in the mainland. It is a professional production base of antibiotic raw materials and preparations in China and a major supplier of non patented drugs in China. The market share of amoxicillin dispersible tablets and Amoxicillin Capsules produced by the company ranks first in the industry.

The "zero defect items" of cephalosporin powder injection, tablet and capsule passed the FDA certification for the first time; The annual output is 1.2 billion powder injections, 4.4 billion capsules and 800 million tablets; It is divided into four dosage forms: powder injection, capsule, tablet and granule; More than 150 specifications of antibiotics were produced. All kinds of products have passed GMP certification and meet the latest national standards.

Staff size:2000-2999 persons
Registered capital:RMB 678 million 555 thousand and 900

Producer:PKU HealthCare Corp., Ltd.is a core member enterprise of Founder group medical and pharmaceutical industry - Peking University medical industry group. It has more than 50 years of pharmaceutical manufacturing history and a national technology center. It is a key backbone enterprise of Chinese medicine, a national innovative pilot enterprise and a key high-tech enterprise of the national torch plan.

Peking University Pharmaceutical has a pharmaceutical manufacturing base built according to international cGMP in Liangjiang New Area, Chongqing. Its products cover more than 10 categories and more than 100 varieties, such as anti-tumor, psychoneurological, cardiovascular, immunosuppressive, anti microbial, antipyretic and analgesic. The company has a perfect quality assurance system, which has passed the FDA and EU GMP certification.

Staff size:About 800 persons

Registered capital:RMB 596 million

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