Doxepin

CAS number： 1668-19-5

Molecular formula： C19H21NO

molecular weight： 279.3761

Chemical structure：

Producers shown on SFDA

(Record date:06/09/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Shanghai Qingping Pharmaceutical Co., Ltd.	GMP	Valid till March 2020
Taicang pharmaceutical factory	GMP	Valid till April 2024
Suzhou Homesun Pharmaceutical Co., Ltd.	GMP	Valid till February 2022

Producers shown on EP

(Quoted from EP website；record date:06/09/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Doxepin hydrochloride	Roche Diagnostics GmbH DE 68305 Mannheim	R1-CEP 1999-094-Rev 01	21/07/2008	VALID	/	Chemistry
Doxepin hydrochloride	OLON S.P.A. IT 20053 Rodano	R1-CEP 2010-280-Rev 02	15/06/2021	VALID	/	Chemistry
Doxepin hydrochloride	TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva	R1-CEP 1999-197-Rev 03	24/10/2019	VALID	/	Chemistry
Doxepin hydrochloride	RAY CHEMICALS PRIVATE LIMITED IN 560 064 Bangalore	R0-CEP 2009-378-Rev 00	05/01/2012	WITHDRAWN BY HOLDER	23/12/2013	Chemistry

Producer:Shanghai Qingping Pharmaceutical Co., Ltd. was founded in 1960, with 3015 square meters of solid preparation workshop, 1250 square meters of 300000 level clean area of workshop and 586 square meters of preparation warehouse; 3661 square meters of API workshop and 650 square meters of 300000 class clean area,; Quality assurance department 460 square meters; Greening accounts for 33.4% of the total area. The company's API workshop passed GMP certification in 2005.Staff size:100-199 persons

Registered capital:RMB 21.38 million

Producer:Taicang pharmaceutical factory was founded in 1958. The new factory covers an area of 46690 square meters, a construction area of 25300 square meters, and the existing fixed assets are 43 million yuan. The new factory has built seven sets of GMP standard API fine drying car rooms according to the requirements of the national GMP specification, each with an annual production capacity of more than 100 tons, and has built a tablet workshop with an annual output of 450 million tablets required by the GMP specification, The factory passed GMP standard acceptance in May 2004 and GMP certificate renewal acceptance in April 2009.

Staff size:50-99 persons

Registered capital:RMB 500 thousand

Producer:Suzhou Homesun Pharmaceutical Co., Ltd.was established on April 17, 2009, production address: Jiangsu Taicang Port Development Zone, petrochemical zone GCL Road on the 12th, registered capital of 98 million yuan, 2.3 million yuan in fixed assets, covers an area of 4.3 million square meters, construction area of 2.5 million square meters.

Company's main products include pharmaceutical intermediates, pharmaceutical raw materials (including sterile APIs), frozen dried powder injection, small volume injection, oral solid dosage forms (tablets and capsules) and inhalation solution. Currently has 17 APIs and small capacity injection workshop, tablets, hard capsule agent through the national GMP certification, with an annual output of: 350 tons of raw material medicine (fine baked package), 1 billion ampoules of small volume injections, 15 million tablets, 1 million capsules agent, product coverage of antitumor, antiviral, central nervous, anti infective, cardiovascular, digestive, antipyretic analgesic class.

Staff size:About 150 persons

Registered capital:RMB 98 million

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

Doxepin

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