01 1Dipharma Francis S. r. l.
01 1Cyclobenzaprine Hydrochloride
01 1Italy
Registration Number : 306MF10003
Registrant's Address : Via Bissone, 5, 20021-Baranzate, Milano, Italy
Initial Date of Registration : 2024-01-11
Latest Date of Registration : 2024-01-11
A Cyclobenzaprine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyclobenzaprine, including repackagers and relabelers. The FDA regulates Cyclobenzaprine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyclobenzaprine 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 Cyclobenzaprine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cyclobenzaprine supplier is an individual or a company that provides Cyclobenzaprine active pharmaceutical ingredient (API) or Cyclobenzaprine finished formulations upon request. The Cyclobenzaprine suppliers may include Cyclobenzaprine API manufacturers, exporters, distributors and traders.
click here to find a list of Cyclobenzaprine 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 Cyclobenzaprine Drug Master File in Japan (Cyclobenzaprine JDMF) empowers Cyclobenzaprine 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 Cyclobenzaprine JDMF during the approval evaluation for pharmaceutical products. At the time of Cyclobenzaprine 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 Cyclobenzaprine suppliers with JDMF on PharmaCompass.
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