Registration Number : 305MF10067
Registrant's Address : Hochstrasse201 8200 Schaffhausen Switzerland
Initial Date of Registration : 2023-05-24
Latest Date of Registration : 2023-12-13
A Cladribine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cladribine, including repackagers and relabelers. The FDA regulates Cladribine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cladribine 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 Cladribine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cladribine supplier is an individual or a company that provides Cladribine active pharmaceutical ingredient (API) or Cladribine finished formulations upon request. The Cladribine suppliers may include Cladribine API manufacturers, exporters, distributors and traders.
click here to find a list of Cladribine 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 Cladribine Drug Master File in Japan (Cladribine JDMF) empowers Cladribine 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 Cladribine JDMF during the approval evaluation for pharmaceutical products. At the time of Cladribine 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 Cladribine suppliers with JDMF on PharmaCompass.
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