01 1RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S. P. A.
01 1Dimenhydrinate
01 1Italy
Registration Number : 217MF10747
Registrant's Address : VIA M. Civitali, 1-20148 MILANO, ITALY
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2010-04-05
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PharmaCompass offers a list of Dimenhydrinate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dimenhydrinate manufacturer or Dimenhydrinate supplier for your needs.
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A Rodovan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rodovan, including repackagers and relabelers. The FDA regulates Rodovan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rodovan 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 Rodovan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rodovan supplier is an individual or a company that provides Rodovan active pharmaceutical ingredient (API) or Rodovan finished formulations upon request. The Rodovan suppliers may include Rodovan API manufacturers, exporters, distributors and traders.
click here to find a list of Rodovan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Rodovan Drug Master File in Japan (Rodovan JDMF) empowers Rodovan 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 Rodovan JDMF during the approval evaluation for pharmaceutical products. At the time of Rodovan 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 Rodovan suppliers with JDMF on PharmaCompass.
