01 1Organic Synthesis Chemicals Co., Ltd.
01 1Japanese Pharmacopoeia isoniazid
01 1Japan
Japanese Pharmacopoeia Isoniazid
Registration Number : 217MF10818
Registrant's Address : 3-10-4 Nihonbashi Ningyocho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2007-10-05
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PharmaCompass offers a list of Isoniazid 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 Isoniazid manufacturer or Isoniazid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isoniazid manufacturer or Isoniazid supplier.
PharmaCompass also assists you with knowing the Isoniazid API Price utilized in the formulation of products. Isoniazid API Price is not always fixed or binding as the Isoniazid Price is obtained through a variety of data sources. The Isoniazid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A HIA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of HIA, including repackagers and relabelers. The FDA regulates HIA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. HIA 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 HIA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A HIA supplier is an individual or a company that provides HIA active pharmaceutical ingredient (API) or HIA finished formulations upon request. The HIA suppliers may include HIA API manufacturers, exporters, distributors and traders.
click here to find a list of HIA 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 HIA Drug Master File in Japan (HIA JDMF) empowers HIA 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 HIA JDMF during the approval evaluation for pharmaceutical products. At the time of HIA 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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