01 1Daiichi Sankyo Propharma Co., Ltd.
01 1Hydromorphone hydrochloride
01 1Japan
Registration Number : 227MF10256
Registrant's Address : 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2015-10-21
Latest Date of Registration : 2017-02-08
A Hydromorphone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydromorphone Hydrochloride, including repackagers and relabelers. The FDA regulates Hydromorphone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydromorphone Hydrochloride supplier is an individual or a company that provides Hydromorphone Hydrochloride active pharmaceutical ingredient (API) or Hydromorphone Hydrochloride finished formulations upon request. The Hydromorphone Hydrochloride suppliers may include Hydromorphone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride Drug Master File in Japan (Hydromorphone Hydrochloride JDMF) empowers Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Hydromorphone Hydrochloride 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 Hydromorphone Hydrochloride suppliers with JDMF on PharmaCompass.
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