Registration Number : 305MF10067
Registrant's Address : Hochstrasse201 8200 Schaffhausen Switzerland
Initial Date of Registration : 2023-05-24
Latest Date of Registration : 2023-12-13
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PharmaCompass offers a list of Cladribine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cladribine manufacturer or Cladribine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cladribine manufacturer or Cladribine supplier.
PharmaCompass also assists you with knowing the Cladribine API Price utilized in the formulation of products. Cladribine API Price is not always fixed or binding as the Cladribine Price is obtained through a variety of data sources. The Cladribine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 2-CdA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-CdA, including repackagers and relabelers. The FDA regulates 2-CdA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-CdA 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 2-CdA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 2-CdA supplier is an individual or a company that provides 2-CdA active pharmaceutical ingredient (API) or 2-CdA finished formulations upon request. The 2-CdA suppliers may include 2-CdA API manufacturers, exporters, distributors and traders.
click here to find a list of 2-CdA 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 2-CdA Drug Master File in Japan (2-CdA JDMF) empowers 2-CdA 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 2-CdA JDMF during the approval evaluation for pharmaceutical products. At the time of 2-CdA 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 2-CdA suppliers with JDMF on PharmaCompass.
