01 1Lonza Guangzhou Pharmaceutical Ltd
01 1Nicotinic acid amide
01 1Switzerland
Registration Number : 226MF10200
Registrant's Address : No. 1202, Building A1, No. 1, Qinghui Middle Road, Nansha District, Guangzhou
Initial Date of Registration : 2014-10-27
Latest Date of Registration : 2016-03-02
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A TPN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TPN, including repackagers and relabelers. The FDA regulates TPN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TPN 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 TPN manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A TPN supplier is an individual or a company that provides TPN active pharmaceutical ingredient (API) or TPN finished formulations upon request. The TPN suppliers may include TPN API manufacturers, exporters, distributors and traders.
click here to find a list of TPN 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 TPN Drug Master File in Japan (TPN JDMF) empowers TPN 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 TPN JDMF during the approval evaluation for pharmaceutical products. At the time of TPN 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 TPN suppliers with JDMF on PharmaCompass.
