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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivabradine, including repackagers and relabelers. The FDA regulates Ivabradine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivabradine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ivabradine supplier is an individual or a company that provides Ivabradine active pharmaceutical ingredient (API) or Ivabradine finished formulations upon request. The Ivabradine suppliers may include Ivabradine API manufacturers, exporters, distributors and traders.
click here to find a list of Ivabradine 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 Drug Master File in Japan (Ivabradine JDMF) empowers Ivabradine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Ivabradine 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 suppliers with JDMF on PharmaCompass.
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