Registration Number : 230MF10037
Registrant's Address : 13, rue Auguste Desgene(') tais, 76210 Bolbec, FRANCE
Initial Date of Registration : 2018-02-26
Latest Date of Registration : 2018-02-26
A Ivabradine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivabradine Hydrochloride, including repackagers and relabelers. The FDA regulates Ivabradine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivabradine 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 Ivabradine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ivabradine Hydrochloride supplier is an individual or a company that provides Ivabradine Hydrochloride active pharmaceutical ingredient (API) or Ivabradine Hydrochloride finished formulations upon request. The Ivabradine Hydrochloride suppliers may include Ivabradine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ivabradine 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 Ivabradine Hydrochloride Drug Master File in Japan (Ivabradine Hydrochloride JDMF) empowers Ivabradine 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 Ivabradine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ivabradine 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 Ivabradine Hydrochloride suppliers with JDMF on PharmaCompass.
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