01 1Procos S. p. A.
01 1Clofedanol Hydrochloride
01 1Italy
Registration Number : 217MF11129
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2009-10-19
A CHLOPHEDIANOL HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CHLOPHEDIANOL HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates CHLOPHEDIANOL HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CHLOPHEDIANOL 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 CHLOPHEDIANOL HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CHLOPHEDIANOL HYDROCHLORIDE supplier is an individual or a company that provides CHLOPHEDIANOL HYDROCHLORIDE active pharmaceutical ingredient (API) or CHLOPHEDIANOL HYDROCHLORIDE finished formulations upon request. The CHLOPHEDIANOL HYDROCHLORIDE suppliers may include CHLOPHEDIANOL HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of CHLOPHEDIANOL 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 CHLOPHEDIANOL HYDROCHLORIDE Drug Master File in Japan (CHLOPHEDIANOL HYDROCHLORIDE JDMF) empowers CHLOPHEDIANOL 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 CHLOPHEDIANOL HYDROCHLORIDE JDMF during the approval evaluation for pharmaceutical products. At the time of CHLOPHEDIANOL 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 CHLOPHEDIANOL HYDROCHLORIDE suppliers with JDMF on PharmaCompass.
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