Diprophylline

CAS number： 479-18-5

Molecular formula： C10H14N4O4

molecular weight： 254.24

Chemical structure：

Producers shown on SFDA

(Record date:11/10/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Shanghai Wonder Pharmaceutical Co., Ltd.	GMP	Valid tillDecember 2023
Hunan Erkang Pharmaceutical Co., Ltd.	GMP	Valid till November 2023
CSPC Innovation Pharmaceutical Co.,Ltd.	GMP	Valid till August 2023
Shanghai Xiandai Hasen(Shangqiu) Pharmaceutical Co., Ltd.	GMP	Valid till January 2019
Shanghai Wandai Pharmaceutical Co., Ltd.	GMP	Valid till February 2019

Producers shown on EP

(Quoted from EP website；record date:11/10/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Diprophylline	CSPC INNOVATION PHARMACEUTICAL CO., LTD. Shijiazhuang City CN	R0-CEP 2009-033 - Rev 00	05/07/2010	Withdrawn by EDQM Failure to CEP procedure	16/04/2012	Chemical

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

Staff size:/

Registered capital:RMB 9 millionv

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