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