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