01 1Alps Pharmaceutical Co., Ltd.
02 1Embio Limited
01 1Japanese Pharmacopoeia dl- methyl ephedrine hydrochloride
02 1Japanese Pharmacopoeia ephedrine hydrochloride (production only)
01 1India
02 1Japan
Japanese Pharmacopoeia dl-Methylephedrine Hydrochloride
Registration Number : 221MF10172
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2009-07-30
Latest Date of Registration : 2009-07-30
Japanese Pharmacopoeia Ephedrine Hydrochloride (for manufacturing only)
Registration Number : 220MF10147
Registrant's Address : 501, 5th Floor, SENTINEL, Central Avenue Road, Hiranandani Gardens, Powai, Mumbai 400...
Initial Date of Registration : 2008-06-10
Latest Date of Registration : 2008-06-10
A Ephedrine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ephedrine Hydrochloride, including repackagers and relabelers. The FDA regulates Ephedrine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ephedrine 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 Ephedrine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ephedrine Hydrochloride supplier is an individual or a company that provides Ephedrine Hydrochloride active pharmaceutical ingredient (API) or Ephedrine Hydrochloride finished formulations upon request. The Ephedrine Hydrochloride suppliers may include Ephedrine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ephedrine 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 Ephedrine Hydrochloride Drug Master File in Japan (Ephedrine Hydrochloride JDMF) empowers Ephedrine 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 Ephedrine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ephedrine 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 Ephedrine Hydrochloride suppliers with JDMF on PharmaCompass.
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