Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Registration Number : 301MF10021
Registrant's Address : 6-8, Fructo(´)s Gelabert 08970 Sant Joan Despi(´)(Barcelona) Spain
Initial Date of Registration : 2019-06-25
Latest Date of Registration : 2019-06-25
A Clozapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clozapine, including repackagers and relabelers. The FDA regulates Clozapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clozapine 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 Clozapine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clozapine supplier is an individual or a company that provides Clozapine active pharmaceutical ingredient (API) or Clozapine finished formulations upon request. The Clozapine suppliers may include Clozapine API manufacturers, exporters, distributors and traders.
click here to find a list of Clozapine 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 Clozapine Drug Master File in Japan (Clozapine JDMF) empowers Clozapine 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 Clozapine JDMF during the approval evaluation for pharmaceutical products. At the time of Clozapine 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 Clozapine suppliers with JDMF on PharmaCompass.
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