Registration Number : 224MF10186
Registrant's Address : 8145 Blazer Drive, Wilmington, DE, 19808, United States
Initial Date of Registration : 2012-09-03
Latest Date of Registration : 2023-07-05
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PharmaCompass offers a list of Mitotane 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 Mitotane manufacturer or Mitotane supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mitotane manufacturer or Mitotane supplier.
PharmaCompass also assists you with knowing the Mitotane API Price utilized in the formulation of products. Mitotane API Price is not always fixed or binding as the Mitotane Price is obtained through a variety of data sources. The Mitotane Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lisodren manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lisodren, including repackagers and relabelers. The FDA regulates Lisodren manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lisodren 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 Lisodren manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lisodren supplier is an individual or a company that provides Lisodren active pharmaceutical ingredient (API) or Lisodren finished formulations upon request. The Lisodren suppliers may include Lisodren API manufacturers, exporters, distributors and traders.
click here to find a list of Lisodren 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 Lisodren Drug Master File in Japan (Lisodren JDMF) empowers Lisodren 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 Lisodren JDMF during the approval evaluation for pharmaceutical products. At the time of Lisodren 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 Lisodren suppliers with JDMF on PharmaCompass.
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