01 1F. I. S. Fabrica Italiana Sintetici S. p. A.
01 1Clomiphene citrate
01 1Italy
Registration Number : 226MF10082
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2014-05-02
Latest Date of Registration : 2017-03-30
A Enclomiphene Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enclomiphene Citrate, including repackagers and relabelers. The FDA regulates Enclomiphene Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enclomiphene Citrate 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 Enclomiphene Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Enclomiphene Citrate supplier is an individual or a company that provides Enclomiphene Citrate active pharmaceutical ingredient (API) or Enclomiphene Citrate finished formulations upon request. The Enclomiphene Citrate suppliers may include Enclomiphene Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Enclomiphene Citrate 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 Enclomiphene Citrate Drug Master File in Japan (Enclomiphene Citrate JDMF) empowers Enclomiphene Citrate 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 Enclomiphene Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Enclomiphene Citrate 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 Enclomiphene Citrate suppliers with JDMF on PharmaCompass.
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