01 1Organic Synthetic 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.
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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 Prestwick3_000161 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_000161, including repackagers and relabelers. The FDA regulates Prestwick3_000161 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_000161 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 Prestwick3_000161 supplier is an individual or a company that provides Prestwick3_000161 active pharmaceutical ingredient (API) or Prestwick3_000161 finished formulations upon request. The Prestwick3_000161 suppliers may include Prestwick3_000161 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 Prestwick3_000161 Drug Master File in Japan (Prestwick3_000161 JDMF) empowers Prestwick3_000161 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 Prestwick3_000161 JDMF during the approval evaluation for pharmaceutical products. At the time of Prestwick3_000161 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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