01 5Kyowa Chemical Industry Co., Ltd.
01 1Dried aluminum hydroxide gel fine "Kyowa Chemical"
02 4Japanese Pharmacopoeia dried aluminum hydroxide gel (produced only)
01 5Japan
Dried aluminum hydroxide gel granules "Kyowa Chemical"
Registration Number : 217MF10837
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2010-02-12
Japanese Pharmacopoeia Dried Aluminum Hydroxide Gel (For manufacturing only)
Registration Number : 221MF10033
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2009-02-09
Latest Date of Registration : 2009-02-09
Japanese Pharmacopoeia Dried Aluminum Hydroxide Gel (For manufacturing only)
Registration Number : 221MF10032
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2009-02-09
Latest Date of Registration : 2009-02-09
Japanese Pharmacopoeia Dried Aluminum Hydroxide Gel (For manufacturing only)
Registration Number : 221MF10031
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2009-02-09
Latest Date of Registration : 2009-02-09
Japanese Pharmacopoeia Dried Aluminum Hydroxide Gel (For manufacturing only)
Registration Number : 221MF10030
Registrant's Address : 305 Yashima Nishimachi, Takamatsu City, Kagawa Prefecture
Initial Date of Registration : 2009-02-09
Latest Date of Registration : 2009-02-09
A Aluminum Hydroxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aluminum Hydroxide, including repackagers and relabelers. The FDA regulates Aluminum Hydroxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aluminum Hydroxide 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 Aluminum Hydroxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aluminum Hydroxide supplier is an individual or a company that provides Aluminum Hydroxide active pharmaceutical ingredient (API) or Aluminum Hydroxide finished formulations upon request. The Aluminum Hydroxide suppliers may include Aluminum Hydroxide API manufacturers, exporters, distributors and traders.
click here to find a list of Aluminum Hydroxide 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 Aluminum Hydroxide Drug Master File in Japan (Aluminum Hydroxide JDMF) empowers Aluminum Hydroxide 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 Aluminum Hydroxide JDMF during the approval evaluation for pharmaceutical products. At the time of Aluminum Hydroxide 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 Aluminum Hydroxide suppliers with JDMF on PharmaCompass.
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