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
A Linaclotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Linaclotide, including repackagers and relabelers. The FDA regulates Linaclotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Linaclotide 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 Linaclotide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Linaclotide supplier is an individual or a company that provides Linaclotide active pharmaceutical ingredient (API) or Linaclotide finished formulations upon request. The Linaclotide suppliers may include Linaclotide API manufacturers, exporters, distributors and traders.
click here to find a list of Linaclotide 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 Linaclotide Drug Master File in Japan (Linaclotide JDMF) empowers Linaclotide 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 Linaclotide JDMF during the approval evaluation for pharmaceutical products. At the time of Linaclotide 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 Linaclotide suppliers with JDMF on PharmaCompass.
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