Registration Number : 305MF10058
Registrant's Address : Muenchensteiner strasse 38, CH-4002, Basel, Switzerland
Initial Date of Registration : 2023-05-10
Latest Date of Registration : 2023-10-25
A Voclosporin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Voclosporin, including repackagers and relabelers. The FDA regulates Voclosporin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Voclosporin 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 Voclosporin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Voclosporin supplier is an individual or a company that provides Voclosporin active pharmaceutical ingredient (API) or Voclosporin finished formulations upon request. The Voclosporin suppliers may include Voclosporin API manufacturers, exporters, distributors and traders.
click here to find a list of Voclosporin 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 Voclosporin Drug Master File in Japan (Voclosporin JDMF) empowers Voclosporin 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 Voclosporin JDMF during the approval evaluation for pharmaceutical products. At the time of Voclosporin 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 Voclosporin suppliers with JDMF on PharmaCompass.
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