Home>APIs>

Aminophylline

CAS number: 317-34-0

Molecular formula: 2(C7H8N4O2).C2H8N2

molecular weight: 420.43

Chemical structure:

Producers shown on SFDA

(Record date:29/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Hunan Erkang Pharmaceutical Co., Ltd.

GMP
Valid till November 2018

Youhua Pharmaceutical (Leshan) Co., Ltd.

GMP
Valid till January 2024

CSPC Innovation Pharmaceutical Co.,Ltd.

GMP
Valid till August 2023

Hebei Guangxiang Pharmaceutical Co., Ltd.

GMP
Valid till September 2024

Jilin Shulan Synthetic Pharmaceutical Co., Ltd.

GMP
Valid till January 2023

Shandong Xinhua Pharmaceutical Co., Ltd.

GMP
Valid till November 2020

Sichuan Xicheng Pharmaceutical Co., Ltd.

GMP
Valid till November 2018

Tianjin Zhongan Pharmaceutical Co., Ltd.

GMP
Valid till January 2021

Jiuquan Dadeli Pharmaceutical Co., Ltd.

GMP
Valid till February 2024



Producers shown on EP

Not showing any


Producer:Hunan Erkang Pharmaceutical Co., Ltd., established in October 2003, is a leading enterprise of pharmaceutical excipients with the largest scale and the most complete varieties in China; It is also one of the few enterprises in China that have the registration approval documents of new penicillin antibiotics - sulbacillin sodium API and finished products  。 In 2014, the company successfully broke through the technical bottleneck of the industrialization of starch plant capsules, a new high-end excipient variety, and became the world's first enterprise in the industrialization of starch capsules  。 The company was listed on Shenzhen Stock Exchange on September 27, 2011. It is the first listed company in China's pharmaceutical excipients industry.

Staff size:About 1700 persons

Registered capital:RMB 2 billion 63 million


Producer:Youhua Pharmaceutical (Leshan) Co., Ltd., formerly known as Sichuan Leshan pharmaceutical factory founded in 1939, now has GMP certification of xanthine series API, preparation GMP certification, sublimated sulfur API GMP issued by the State Food and Drug Administration and passed the GMP certification of linezolid API. At the same time, the company actively expands its overseas business, exports APIs to the United States, the European Union and Southeast Asia, and has also completed international certification of corresponding quality systems, including ISO9000, ISO14000, ISO22000, halal & kosher and SQF.

The annual production capacity of the company's preparations is 3 billion tablets, 1 billion capsules, 2.4 million boxes of rods, 1 billion bags of granules and 100 million creams, 2000 tons of traditional Chinese medicine and 1000 tons of raw materials.

Staff size:100-199 persons

Registered capital:RMB 91 million


Producer:CSPC Innovation Pharmaceutical Co.,Ltd. is a manufacturer of APIs, mainly engaged in the R & D and production of APIs, pharmaceutical intermediates and psychotropic drugs, and has developed a new technology for the recovery of tea sodium mother liquor resin. Its products include caffeine, dihydroxypropyltheophylline, theobromine, pentoxifylline and doxofylline.

Staff size:1600-1699 persons

Registered capital:RMB 546 million


Producer:Hebei Guangxiang Pharmaceutical Co., Ltd., established in February 2017, is located in Huanghua Lingang Economic and Technological Development Zone, Cangzhou City, Hebei Province, covering a total area of 489.2 Mu and a total construction area of 250000 square meters. At present, it has a registered capital of 670 million yuan and is a subsidiary of Shisi Pharmaceutical Group. Shisiyao is one of the leading manufacturers in China's pharmaceutical industry. For many consecutive years, it has ranked among the top 100 enterprises in China's pharmaceutical industry, the top 10 excellent enterprise brands for the export of preparations in China's chemical pharmaceutical industry, and the national demonstration enterprise of technological innovation. With national enterprise technology center, national and local joint engineering laboratories and other national platforms, it has strong R & D strength.

Staff size:400-499 persons

Registered capital:RMB 670 million


Producer:Jilin Shulan Synthetic Pharmaceutical Co., Ltd. is located in Shulan City, covering an area of 120000 square meters. Now the company is preparing to build the world's largest caffeine production base (with an annual output of 10000 tons) in Jilin economic development zone. The company's leading products are chemical raw materials such as caffeine, theophylline, aminophylline and cocaine, with an annual comprehensive production capacity of 3000 tons, It is one of the main chemical API manufacturers in Jilin Province.

The company's products are produced in strict accordance with GMP, American cGMP and ichq7a standards. The leading product caffeine has obtained halal, kosher and Japanese PMDA certification, and passed the on-site inspection of FDA twice in 2011 and 2015. In order to better improve the management level of the company, the company has passed iso9001:2015, iso14001:2015, ISO22000:2005 and BRC certification. Theophylline has passed the official certification in Mexico and PMDA certification in Japan.

Staff size:100-199 persons

Registered capital:RMB 15.758 million


Producer:Shandong Xinhua Pharmaceutical Co., Ltd., established in Jiaodong Anti Japanese base in 1943, is the first chemical synthetic pharmaceutical enterprise in China, an important global production and export base of antipyretic and analgesic drugs, and an important domestic manufacturer of cardio cerebrovascular, anti infection and central nervous system. It has three pillar industries of chemical raw materials, pharmaceutical preparations and pharmaceutical intermediates, five industrial parks and 13 subsidiaries. The annual production capacity of chemical APIs is 40000 tons, pharmaceutical intermediates is 500000 tons, solid preparations are 28 billion tablets (tablets), and injections are 1 billion.

At present, all the drugs in production of Xinhua Pharmaceutical have passed the new national GMP certification, 18 products have passed the FDA inspection, 10 products have obtained the EU cos certificate, and the tablets have passed the MHRA audit of the UK drug and health products administration. More than 3 billion tablets have been exported to the EU high-end market, It has become one of the first 15 leading enterprises implementing the internationalization strategy of preparations in China and one of the top ten enterprises in the export of preparations in China.

Staff size:About 7000 persons

Registered capital:RMB 627 million 400 thousand


Producer:Sichuan Xicheng Pharmaceutical Co., Ltd. has been renamed Youhua Pharmaceutical (Leshan) Co., Ltd., formerly known as the original Sichuan Leshan pharmaceutical factory founded in 1939. Its registered address is No. 2, Linjiang North Road, Leshan high tech Zone, Sichuan Province, with a registered capital of 91 million yuan.

The company now has GMP certification of xanthine series API, preparation GMP certification, sublimated sulfur API and linezolid API issued by the State Food and drug administration. At the same time, the company actively expands its overseas business, exports APIs to the United States, the European Union and Southeast Asia, and has also completed international certification of corresponding quality systems, including ISO9000, ISO14000, ISO22000, halal & kosher and SQF.

At present, the company has 130 national drug approved varieties (including raw material varieties), 1 food additive variety and 1 medical device product. It is the only designated manufacturer of caffeine drugs and food additives in Southwest China and the only manufacturer of medical masks in Leshan. The preparation includes seven dosage forms: tablets, capsules, rods, granules, powders, ointments and creams. The annual production capacity of the preparation is 3 billion tablets, 1 billion capsules, 2.4 million boxes of rods, 1 billion bags of granules and 100 million creams, 2000 tons of traditional Chinese medicine and 1000 tons of raw materials.

Staff size:100-199 persons

Registered capital:RMB 91 million


Producer:Tianjin Zhongan Pharmaceutical Co., Ltd.,   The company covers an area of 82000 square meters, a construction area of 31600 square meters and a green space of 13300 square meters.

It mainly produces 10 kinds of chemical synthetic APIs, with an annual production capacity of 4000 tons. The leading products are caffeine and metronidazole. Both have obtained the EU cos certificate and the DMF registration of the US FDA. It has successively passed the national GMP and ISO9001:2008 certification, as well as the international food safety certification of BRC, kof-k and Halal.

Staff size:About 50 persons

Registered capital:RMB 11.088 million


Producer:Jiuquan Dadeli Pharmaceutical Co., Ltd., a holding subsidiary of Lanzhou Dadeli Pharmaceutical Group, is a high-tech enterprise specializing in drug R & D, production and sales. There are 146 drug approval numbers, including 32 API approvals. The company has more than ten production lines for solid preparations, small volume injections, lyophilized powder injections, biochemical APIs, chemical APIs, traditional Chinese medicine extraction, traditional Chinese medicine decoction pieces, etc., all of which have passed the national GMP certification.

Staff size:100-199 persons

Registered capital:RMB 59.43 million


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