01 1Guangxi Nanning Baihui Pharmaceutical Group Nanning Bowbo Biological Engineering Co., Ltd.
01 1Bromelain L
01 1China
Registration Number : 220MF10157
Registrant's Address : Building D, Yinkai Industrial Park, Nanyan Line, Shajing Avenue, Nanning, China
Initial Date of Registration : 2008-06-30
Latest Date of Registration : 2008-06-30
A Bromelain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromelain, including repackagers and relabelers. The FDA regulates Bromelain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromelain 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 Bromelain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bromelain supplier is an individual or a company that provides Bromelain active pharmaceutical ingredient (API) or Bromelain finished formulations upon request. The Bromelain suppliers may include Bromelain API manufacturers, exporters, distributors and traders.
click here to find a list of Bromelain 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 Bromelain Drug Master File in Japan (Bromelain JDMF) empowers Bromelain 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 Bromelain JDMF during the approval evaluation for pharmaceutical products. At the time of Bromelain 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 Bromelain suppliers with JDMF on PharmaCompass.
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