01 1Yashiro Pharmaceutical Co., Ltd.
01 1Aminophylline hydrate
01 1Blank
Registration Number : 222MF10082
Registrant's Address : 10-2 Yoshida Shimojima, Higashiosaka City, Osaka Prefecture
Initial Date of Registration : 2010-03-09
Latest Date of Registration : 2010-03-09
A Aminophylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aminophylline, including repackagers and relabelers. The FDA regulates Aminophylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aminophylline 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 Aminophylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aminophylline supplier is an individual or a company that provides Aminophylline active pharmaceutical ingredient (API) or Aminophylline finished formulations upon request. The Aminophylline suppliers may include Aminophylline API manufacturers, exporters, distributors and traders.
click here to find a list of Aminophylline 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 Aminophylline Drug Master File in Japan (Aminophylline JDMF) empowers Aminophylline 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 Aminophylline JDMF during the approval evaluation for pharmaceutical products. At the time of Aminophylline 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 Aminophylline suppliers with JDMF on PharmaCompass.
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