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
A Isoniazid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoniazid, including repackagers and relabelers. The FDA regulates Isoniazid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoniazid 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 Isoniazid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isoniazid supplier is an individual or a company that provides Isoniazid active pharmaceutical ingredient (API) or Isoniazid finished formulations upon request. The Isoniazid suppliers may include Isoniazid API manufacturers, exporters, distributors and traders.
click here to find a list of Isoniazid 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 Isoniazid Drug Master File in Japan (Isoniazid JDMF) empowers Isoniazid 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 Isoniazid JDMF during the approval evaluation for pharmaceutical products. At the time of Isoniazid 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 Isoniazid suppliers with JDMF on PharmaCompass.
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