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Theophylline

CAS number: 58-55-9

Molecular formula: C7H8N4O2

molecular weight: 180.16

Chemical structure:

Producers shown on SFDA

(Record date:07/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Hansheng Pharmaceutical Co., Ltd.

GMP
Valid till May 2024

Liaoning Yaolian Pharmaceutical Co., Ltd. 

GMP
Valid till February 2024

Jilin Shulan Synthetic Pharmaceutical Co., Ltd. 

GMP, DMF
Valid till January 2023

Shandong Xinhua Pharmaceutical Co., Ltd.

GMP
Valid till November 2020

Youhua Pharmaceutical (Leshan) Co., Ltd.

GMP
Valid till January 2024

Sichuan Xicheng Pharmaceutical Co., Ltd.

GMP
Valid till November 2018

CSPC Innovation Pharmaceutical Co.,Ltd. 

GMP
Valid till August 2023

Hebei Guangxiang Pharmaceutical Co., Ltd.

GMP
Valid till September 2024

Tianjin Zhongan Pharmaceutical Co., Ltd.

GMP
Valid till January 2021

Shanghai Wonder Pharmaceutical Co., Ltd.

GMP
Valid till December 2023

Zhejiang Changming Pharmaceutical Co., Ltd.

GMPValid till February 2024

Jiuquan Dadeli Pharmaceutical Co., Ltd.

GMP
Valid till February 2024

Shanghai Wonder Pharmaceutical Co., Ltd.

GMP
Valid till February 2019

Hunan Erkang Pharmaceutical Co., Ltd.

GMP
Valid till November 2023

Heilongjiang Fuhe Huaxing Pharmaceutical Group Co., Ltd.

GMP
Valid till February 2022

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

GMP
Valid till February 2024

Fu'an Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd.

GMP
Valid till July 2023

Zhejiang Anglikang Pharmaceutical Co., Ltd.

GMP
Valid till March 2020

 Dandong Yichuang Pharmaceutical Co., Ltd.

GMP
Valid till June 2020


Producers shown on EP

(Quoted from EP website;record date:07/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Theophylline-ethylenediamine
SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH DE 32423 Minden
  R1-CEP 2007-288-Rev 01
15/12/2015
VALID
/Chemistry
Theophylline
SHANDONG XINHUA PHARMACEUTICAL CO., LTD. CN 255 086 Zibo
  R1-CEP 1998-004-Rev 07
02/02/2017
VALID
/
Chemistry
Theophylline
Jilin Shulan Synthetic Pharmaceutical Co. Ltd. CN 132 600 Shulan City
  R1-CEP 2004-139-Rev 00
19/09/2011
WITHDRAWN BY HOLDER
27/02/2014
Chemistry
Theophylline-ethylenediamine
CSPC INNOVATION PHARMACEUTICAL CO., LTD. CN 051 430 Shijiazhuang City
  R0-CEP 2007-345-Rev 01
09/02/2010
WITHDRAWN BY EDQM
16/04/2012
Chemistry
Theophylline
KW Pfannenschmidt GmbH DE 22459 Hamburg
  R0-CEP 1998-018-Rev 01
29/07/2002
WITHDRAWN BY EDQM
02/08/2004
Chemistry
Theophylline
CSPC INNOVATION PHARMACEUTICAL CO., LTD. CN 051 430 Shijiazhuang City
  R0-CEP 2006-087-Rev 01
05/09/2008
WITHDRAWN BY EDQM
16/04/2012
Chemistry
Theophylline
SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH DE 32423 Minden
  R1-CEP 1998-011-Rev 05
15/12/2015
VALID
/
Chemistry
Theophylline monohydrate
SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH DE 32423 Minden
  R1-CEP 1998-010-Rev 06
15/12/2015
VALID
/
Chemistry
TheophyllineBakul Aromatics And Chemicals Ltd IN 400 018 Worli, Bombay Mumbai
  R1-CEP 1998-094-Rev 01
18/02/2010
WITHDRAWN BY EDQM
09/01/2014
Chemistry
Theophylline-ethylenediamine
Jilin Shulan Synthetic Pharmaceutical Co. Ltd. CN 132 600 Shulan City
  R1-CEP 2004-140-Rev 00
19/09/2011
WITHDRAWN BY HOLDER
27/02/2014
Chemistry
Theophylline-ethylenediamine hydrate
SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH DE 32423 Minden
  R1-CEP 2007-289-Rev 01
15/12/2015
VALID
/
Chemistry



Producer:Hansheng Pharmaceutical Co., Ltd.registered in 1996 with a registered capital of 80 million yuan, is also the first genetic engineering product manufacturer in China to pass GMP certification. The company covers an area of 263 Mu and a construction area of more than 50000 square meters. The company has 5 GMP certified production lines.

Staff size:100-199 persons

Registered capital:RMB 80 million 


Producer:Liaoning Yaolian Pharmaceutical Co., Ltd. was established in 2008, covering an area of about 90000 square meters, including water needle workshop, freeze-dried powder workshop, solid preparation workshop, raw material synthesis workshop, hormone and anti-cancer workshop, laboratory and relevant auxiliary facilities. The total investment is 350 million yuan, the designed production capacity is 100 million injections and more than 1 billion boxes of solid preparations, which can form an output value of 10 billion yuan / year after full delivery.

Staff size:200-299 persons

Registered capital:RMB 110 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: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: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, Hhalal & 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: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: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:Shanghai Wonder Pharmaceutical Co., Ltd. was founded in 1989 and merged with Shanghai Wandai Pharmaceutical Co., Ltd. in October 2016. The combined production plant covers an area of 15100 square meters, a workshop building area of 10030 square meters, a warehouse building area of 2700 square meters, an office building area of 2900 square meters, a greening area of 5920 square meters, and the plant environment is standardized and clean.

Wonder pharmaceutical is a GMP factory specializing in the production of API. It is managed in strict accordance with GMP procedures and has passed FDA audit for several times. It is a qualified supplier of several multinational companies.

Staff size:50-99 persons

Registered capital:RMB 59 million


Producer:Zhejiang Changming Pharmaceutical Co., Ltd. has a registered capital of 50 million yuan, covers an area of more than 90 Mu and employs more than 250 people,

It has a modern workshop in line with GMP standards, and has passed the new domestic GMP certification, FDA review, EU official review, ISO9001 quality management system certification, ISO14001 environmental management system certification and OHSAS18000 occupational health and safety management system certification.

Staff size:200-299 persons

Registered capital:RMB 50 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


Producer:Shanghai Wandai Pharmaceutical Co., Ltd., which has been cancelled.

Staff size:/

Registered capital:RMB 9 million


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:Heilongjiang Fuhe Pharmaceutical Group Co., Ltd. (formerly Heilongjiang Fuhe Huaxing Pharmaceutical Group Co., Ltd.) is subordinate to Fuhe group. The production base covers an area of 312000 square meters. The company has dozens of dosage forms and 150 varieties such as tablets, injections, capsules and APIs. Fuhe Huaxing Industrial Park
The annual output is 500 million capsules, 50 million bottles of oral liquid, 100 million bags of granules and 20 million bottles of freeze-dried powder injection.
Staff size:300-399 persons

Registered capital:RMB 229.3 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:Fu'an Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd., a subsidiary of Fu'an Pharmaceutical (Group) Co., Ltd., is the production base of antitumor API of the group. Founded in August 1992, Tianheng has been engaged in the pharmaceutical industry for more than 20 years and has fully passed the national GMP certification. The enterprise has national first-class medical science and technology strength and medical science and technology research center.

Staff size:400-499 persons

Registered capital:RMB 415 million


Producer:Zhejiang Anglikang Pharmaceutical Co., Ltd., established in December 2001, is mainly engaged in the R & D, production and sales of chemical APIs and preparations. It owns a holding subsidiary of Liujia. A perfect quality management system has been established, covering the whole process from product R & D, raw and auxiliary material procurement, production and quality control, warehousing, product distribution to sales tracking, and the company's internal control quality standards higher than the national legal standards have been formulated in accordance with GMP specifications to ensure product quality.
Staff size:About 900 persons

Registered capital:RMB 95 million 950 thousand


Producer:The predecessor of Dandong Yichuang Pharmaceutical Co., Ltd. is the former Dandong pharmaceutical factory. The former Dandong pharmaceutical factory was founded in 1954 and is a large state-owned enterprise. Dandong Yichuang Pharmaceutical Co., Ltd. is a joint-stock company transformed on this basis in December 2003. The registered capital of the company is 7.14 million yuan and has total assets of 460 million yuan. The new plant is located in the Binhai west area of Donggang Economic Development Zone, covering an area of 131 mu with a total investment of nearly 240 million yuan. As of June 2015, it has completed the new national GMP certification of small volume injection, solid oral preparation and synthetic API workshop and obtained the certificate. The company's main product dosage forms officially reached production in 2015. The new plant has formed a production capacity of 240 tons of chemical APIs, 3 billion tablets, 50 million freeze-dried powder injections and 50 million water injections.

Staff size:200-299 persons

Registered capital:RMB 7 million 142 thousand and 857


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