01 1Permakem Asia Co., Ltd.
01 1Chloride calpronium
01 1Japan
Registration Number : 217MF10701
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2007-03-05
A L(-)-Carnitine hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L(-)-Carnitine hydrochloride, including repackagers and relabelers. The FDA regulates L(-)-Carnitine hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L(-)-Carnitine 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 L(-)-Carnitine hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L(-)-Carnitine hydrochloride supplier is an individual or a company that provides L(-)-Carnitine hydrochloride active pharmaceutical ingredient (API) or L(-)-Carnitine hydrochloride finished formulations upon request. The L(-)-Carnitine hydrochloride suppliers may include L(-)-Carnitine hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of L(-)-Carnitine 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 L(-)-Carnitine hydrochloride Drug Master File in Japan (L(-)-Carnitine hydrochloride JDMF) empowers L(-)-Carnitine 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 L(-)-Carnitine hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of L(-)-Carnitine 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 L(-)-Carnitine hydrochloride suppliers with JDMF on PharmaCompass.
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