01 1Sanwa Chemical Co., Ltd.
01 1Japan Pharmaceutical Codex mesylate address Roh chromium mono amino guanidine (production only)
01 1Japan
Adrenochrome monoaminoguanidine mesylate (for manufacturing only)
Registration Number : 218MF10557
Registrant's Address : 24-8 Tamura 9-chome, Hiratsuka City, Kanagawa Prefecture
Initial Date of Registration : 2006-06-02
Latest Date of Registration : 2010-03-23
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PharmaCompass offers a list of GUANIDINE HYDROCHLORIDE API API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right GUANIDINE HYDROCHLORIDE API manufacturer or GUANIDINE HYDROCHLORIDE API supplier for your needs.
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PharmaCompass also assists you with knowing the GUANIDINE HYDROCHLORIDE API API Price utilized in the formulation of products. GUANIDINE HYDROCHLORIDE API API Price is not always fixed or binding as the GUANIDINE HYDROCHLORIDE API Price is obtained through a variety of data sources. The GUANIDINE HYDROCHLORIDE API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A GUANIDINE HYDROCHLORIDE API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GUANIDINE HYDROCHLORIDE API, including repackagers and relabelers. The FDA regulates GUANIDINE HYDROCHLORIDE API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GUANIDINE HYDROCHLORIDE API API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A GUANIDINE HYDROCHLORIDE API supplier is an individual or a company that provides GUANIDINE HYDROCHLORIDE API active pharmaceutical ingredient (API) or GUANIDINE HYDROCHLORIDE API finished formulations upon request. The GUANIDINE HYDROCHLORIDE API suppliers may include GUANIDINE HYDROCHLORIDE API API manufacturers, exporters, distributors and traders.
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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 GUANIDINE HYDROCHLORIDE API Drug Master File in Japan (GUANIDINE HYDROCHLORIDE API JDMF) empowers GUANIDINE HYDROCHLORIDE API 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 GUANIDINE HYDROCHLORIDE API JDMF during the approval evaluation for pharmaceutical products. At the time of GUANIDINE HYDROCHLORIDE API JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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