01 1Organic Synthetic Chemicals Industry 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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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, and COA 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, and COA 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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