01 1Hebei Guangxiang Pharmaceutical Co. , Ltd.
02 2Shandong Xinhua Pharmaceutical Co. , Ltd.
03 1Shizuoka Caffeine Industry Co., Ltd.
04 1Siegfried PharmaChemikalien Minden GmbH
05 1Yashiro Pharmaceutical Co., Ltd.
01 2Japanese Pharmacopoeia theophylline (production only)
02 2Theophylline
03 1Theophylline PT
04 1Theophylline Theophylline anhydrous
01 3China
02 1Japan
03 1Switzerland
04 1Blank
Registration Number : 304MF10162
Registrant's Address : The East of Jingliu Road, West of Cangzhou Lingang Economic and Technological Develop...
Initial Date of Registration : 2022-12-23
Latest Date of Registration : 2022-12-23
Japanese Pharmacopoeia Theophylline (for manufacturing only)
Registration Number : 217MF10613
Registrant's Address : 129 Suidocho, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2023-12-22
Registration Number : 219MF10215
Registrant's Address : No. 14 Dongyi Road, Zhangdian Zibo, Shandong, P. R. China
Initial Date of Registration : 2007-06-25
Latest Date of Registration : 2007-06-25
Japanese Pharmacopoeia Theophylline (for manufacturing only)
Registration Number : 217MF10482
Registrant's Address : No. 1, Lutai Road, High-tech District, Zibo, Shandong, P. R. China
Initial Date of Registration : 2005-09-06
Latest Date of Registration : 2012-02-01
Registration Number : 217MF10989
Registrant's Address : Karlstrasse 15, 32423, Minden, Federal Republic of Germany
Initial Date of Registration : 2005-11-21
Latest Date of Registration : 2006-10-06
Registration Number : 218MF10248
Registrant's Address : 10-2 Yoshida Shimojima, Higashiosaka City, Osaka Prefecture
Initial Date of Registration : 2006-02-16
Latest Date of Registration : 2009-10-08
A Theophylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Theophylline, including repackagers and relabelers. The FDA regulates Theophylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Theophylline API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Theophylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Theophylline supplier is an individual or a company that provides Theophylline active pharmaceutical ingredient (API) or Theophylline finished formulations upon request. The Theophylline suppliers may include Theophylline API manufacturers, exporters, distributors and traders.
click here to find a list of Theophylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Theophylline Drug Master File in Japan (Theophylline JDMF) empowers Theophylline API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Theophylline JDMF during the approval evaluation for pharmaceutical products. At the time of Theophylline JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Theophylline suppliers with JDMF on PharmaCompass.
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