01 1Heraeus Precious Metals GmbH & Co. K.G.
02 1Nippon Rika Pharmaceuticals Co., Ltd.
01 15-Aminolevulinic acid hydrochloride
02 1Aminolevulinic acid hydrochloride salt
01 1Germany
02 1Japan
5-Aminolevulinic acid hydrochloride
Registration Number : 224MF10095
Registrant's Address : Heraeusstr. 12-14; 63450 Hanau; Germany
Initial Date of Registration : 2012-04-27
Latest Date of Registration : 2024-06-18
Aminolevulinic acid hydrochloride
Registration Number : 229MF10010
Registrant's Address : 2-2 Nihonbashi Honcho 4-chome, Chuo-ku, Tokyo
Initial Date of Registration : 2017-01-18
Latest Date of Registration : 2017-01-18
A Levulan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levulan, including repackagers and relabelers. The FDA regulates Levulan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levulan 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 Levulan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levulan supplier is an individual or a company that provides Levulan active pharmaceutical ingredient (API) or Levulan finished formulations upon request. The Levulan suppliers may include Levulan API manufacturers, exporters, distributors and traders.
click here to find a list of Levulan 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 Levulan Drug Master File in Japan (Levulan JDMF) empowers Levulan 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 Levulan JDMF during the approval evaluation for pharmaceutical products. At the time of Levulan 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 Levulan suppliers with JDMF on PharmaCompass.
We have 2 companies offering Levulan
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
