01 1Ace Japan Co., Ltd.
02 1SperaNexus Inc.
01 1Hydrochloric acid dilazep
02 1Japanese Pharmacopoeia dilazep hydrochloride hydrate
01 2Japan
Japanese Pharmacopoeia Dilazep Hydrochloride Hydrate
Registration Number : 218MF10955
Registrant's Address : 5850-1 Higashine-ko, Higashine City, Yamagata Prefecture
Initial Date of Registration : 2006-11-24
Latest Date of Registration : 2006-11-24
Registration Number : 217MF10038
Registrant's Address : 4-8-2 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2010-02-09
A Dilazep manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dilazep, including repackagers and relabelers. The FDA regulates Dilazep manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dilazep 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 Dilazep manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dilazep supplier is an individual or a company that provides Dilazep active pharmaceutical ingredient (API) or Dilazep finished formulations upon request. The Dilazep suppliers may include Dilazep API manufacturers, exporters, distributors and traders.
click here to find a list of Dilazep 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 Dilazep Drug Master File in Japan (Dilazep JDMF) empowers Dilazep 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 Dilazep JDMF during the approval evaluation for pharmaceutical products. At the time of Dilazep 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 Dilazep suppliers with JDMF on PharmaCompass.
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