01 1Shionogi Pharma Co., Ltd.
02 1Takeda Pharmaceutical Company Limited
01 1Morphine hydrochloride hydrate
02 1Morphine hydrochloride hydrate "Takeda"
01 2Japan
Morphine hydrochloride hydrate
Registration Number : 304MF10043
Registrant's Address : 2-5-1 Mishima, Settsu City, Osaka Prefecture
Initial Date of Registration : 2022-02-24
Latest Date of Registration : 2022-02-24
Morphine hydrochloride hydrate "Takeda"
Registration Number : 218MF10629
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 4-1-1
Initial Date of Registration : 2006-07-20
Latest Date of Registration : 2022-03-16
A Morphine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Morphine Hydrochloride, including repackagers and relabelers. The FDA regulates Morphine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Morphine 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 Morphine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Morphine Hydrochloride supplier is an individual or a company that provides Morphine Hydrochloride active pharmaceutical ingredient (API) or Morphine Hydrochloride finished formulations upon request. The Morphine Hydrochloride suppliers may include Morphine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Morphine 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 Morphine Hydrochloride Drug Master File in Japan (Morphine Hydrochloride JDMF) empowers Morphine 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 Morphine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Morphine 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 Morphine Hydrochloride suppliers with JDMF on PharmaCompass.
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