01 1Kyushu Hakusui Co., Ltd.
02 1Sakai Chemical Industry Co., Ltd.
01 1Japanese Pharmacopoeia zinc oxide
02 1Japanese Pharmacopoeia zinc oxide (production only)
01 2Japan
Japanese Pharmacopoeia Zinc Oxide "For manufacturing purposes only"
Registration Number : 218MF11030
Registrant's Address : 669 Yokota, Iizuka City, Fukuoka Prefecture
Initial Date of Registration : 2006-12-28
Latest Date of Registration : 2006-12-28
Japanese Pharmacopoeia Zinc Oxide (for manufacturing only)
Registration Number : 217MF10467
Registrant's Address : Osaka Prefecture Sakai City Sakai Ward Ebisumachi Nishi 1-23
Initial Date of Registration : 2005-08-24
Latest Date of Registration : 2006-07-03
A Zinc Oxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zinc Oxide, including repackagers and relabelers. The FDA regulates Zinc Oxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zinc Oxide 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 Zinc Oxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zinc Oxide supplier is an individual or a company that provides Zinc Oxide active pharmaceutical ingredient (API) or Zinc Oxide finished formulations upon request. The Zinc Oxide suppliers may include Zinc Oxide API manufacturers, exporters, distributors and traders.
click here to find a list of Zinc Oxide 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 Zinc Oxide Drug Master File in Japan (Zinc Oxide JDMF) empowers Zinc Oxide 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 Zinc Oxide JDMF during the approval evaluation for pharmaceutical products. At the time of Zinc Oxide 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 Zinc Oxide suppliers with JDMF on PharmaCompass.
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