01 1COSMA S. P. A.
01 1Hydroxy Jinpa model salt
01 1Italy
Registration Number : 218MF11037
Registrant's Address : Via Colleoni 15/17, 24040 Ciserano(BG)・Italy
Initial Date of Registration : 2006-12-28
Latest Date of Registration : 2021-10-21
A Hydroxyzine Pamoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxyzine Pamoate, including repackagers and relabelers. The FDA regulates Hydroxyzine Pamoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxyzine Pamoate 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 Hydroxyzine Pamoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxyzine Pamoate supplier is an individual or a company that provides Hydroxyzine Pamoate active pharmaceutical ingredient (API) or Hydroxyzine Pamoate finished formulations upon request. The Hydroxyzine Pamoate suppliers may include Hydroxyzine Pamoate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxyzine Pamoate 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 Hydroxyzine Pamoate Drug Master File in Japan (Hydroxyzine Pamoate JDMF) empowers Hydroxyzine Pamoate 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 Hydroxyzine Pamoate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydroxyzine Pamoate 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 Hydroxyzine Pamoate suppliers with JDMF on PharmaCompass.
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