01 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
01 1Japan Pharmaceutical Codex tramazoline hydrochloride salt production dedicated
01 1Japan
Japanese Pharmacopoeia Non-Drug Standard Tramazoline Hydrochloride For manufacturing only
Registration Number : 220MF10207
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2008-09-29
Latest Date of Registration : 2008-09-29
A Tramazoline Hydrochloride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tramazoline Hydrochloride Monohydrate, including repackagers and relabelers. The FDA regulates Tramazoline Hydrochloride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tramazoline Hydrochloride Monohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Tramazoline Hydrochloride Monohydrate supplier is an individual or a company that provides Tramazoline Hydrochloride Monohydrate active pharmaceutical ingredient (API) or Tramazoline Hydrochloride Monohydrate finished formulations upon request. The Tramazoline Hydrochloride Monohydrate suppliers may include Tramazoline Hydrochloride Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Tramazoline Hydrochloride Monohydrate 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 Tramazoline Hydrochloride Monohydrate Drug Master File in Japan (Tramazoline Hydrochloride Monohydrate JDMF) empowers Tramazoline Hydrochloride Monohydrate 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 Tramazoline Hydrochloride Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Tramazoline Hydrochloride Monohydrate 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 Tramazoline Hydrochloride Monohydrate suppliers with JDMF on PharmaCompass.
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