01 1Corden Pharma Colorado, Inc.
01 1Linaclotide
01 1Germany
Registration Number : 231MF10090
Registrant's Address : 2075 North 55th Street Boulder, Colorado 80301-2880, U.S. S. A
Initial Date of Registration : 2019-04-16
Latest Date of Registration : 2019-04-16
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PharmaCompass offers a list of Linaclotide 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 Linaclotide manufacturer or Linaclotide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Linaclotide manufacturer or Linaclotide supplier.
PharmaCompass also assists you with knowing the Linaclotide API Price utilized in the formulation of products. Linaclotide API Price is not always fixed or binding as the Linaclotide Price is obtained through a variety of data sources. The Linaclotide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Linzess manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linzess, including repackagers and relabelers. The FDA regulates Linzess manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linzess 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 Linzess manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Linzess supplier is an individual or a company that provides Linzess active pharmaceutical ingredient (API) or Linzess finished formulations upon request. The Linzess suppliers may include Linzess API manufacturers, exporters, distributors and traders.
click here to find a list of Linzess 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 Linzess Drug Master File in Japan (Linzess JDMF) empowers Linzess 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 Linzess JDMF during the approval evaluation for pharmaceutical products. At the time of Linzess 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 Linzess suppliers with JDMF on PharmaCompass.
