01 1CyDex Pharmaceuticals, Inc.
01 1CAPTISOL
01 1U.S.A
Registration Number : 227MF20001
Registrant's Address : 2033 Becker Drive, Suite 310 Lawrence, KS 66047 United States
Initial Date of Registration : 2015-08-31
Latest Date of Registration : 2024-12-11
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PharmaCompass offers a list of Beta-Cyclodextrin API 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 Beta-Cyclodextrin API manufacturer or Beta-Cyclodextrin API supplier for your needs.
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PharmaCompass also assists you with knowing the Beta-Cyclodextrin API API Price utilized in the formulation of products. Beta-Cyclodextrin API API Price is not always fixed or binding as the Beta-Cyclodextrin API Price is obtained through a variety of data sources. The Beta-Cyclodextrin API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Betadex (NF/INN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betadex (NF/INN), including repackagers and relabelers. The FDA regulates Betadex (NF/INN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betadex (NF/INN) API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Betadex (NF/INN) supplier is an individual or a company that provides Betadex (NF/INN) active pharmaceutical ingredient (API) or Betadex (NF/INN) finished formulations upon request. The Betadex (NF/INN) suppliers may include Betadex (NF/INN) API manufacturers, exporters, distributors and traders.
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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 Betadex (NF/INN) Drug Master File in Japan (Betadex (NF/INN) JDMF) empowers Betadex (NF/INN) 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 Betadex (NF/INN) JDMF during the approval evaluation for pharmaceutical products. At the time of Betadex (NF/INN) JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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