01 1Lonza Guangzhou Pharmaceutical Ltd
01 1Nicotinic acid amide
01 1Switzerland
Registration Number : 226MF10200
Registrant's Address : No. 127, Building C1, No. 1 Qingsheng Avenue, Nansha District, Guangzhou, PRC
Initial Date of Registration : 2014-10-27
Latest Date of Registration : 2016-03-02
A Niacinamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niacinamide, including repackagers and relabelers. The FDA regulates Niacinamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niacinamide 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 Niacinamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niacinamide supplier is an individual or a company that provides Niacinamide active pharmaceutical ingredient (API) or Niacinamide finished formulations upon request. The Niacinamide suppliers may include Niacinamide API manufacturers, exporters, distributors and traders.
click here to find a list of Niacinamide 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 Niacinamide Drug Master File in Japan (Niacinamide JDMF) empowers Niacinamide 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 Niacinamide JDMF during the approval evaluation for pharmaceutical products. At the time of Niacinamide 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 Niacinamide suppliers with JDMF on PharmaCompass.
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