01 2LABORATORI ALCHEMIA SRL
01 2Ramosetron hydrochloride
01 2Italy
Registration Number : 221MF10177
Registrant's Address : Via San Faustino, 68 20134 Milano-Italy
Initial Date of Registration : 2009-08-07
Latest Date of Registration : 2009-08-07
Registration Number : 226MF10230
Registrant's Address : Via San Faustino, 68 20134 Milano-Italy
Initial Date of Registration : 2014-12-08
Latest Date of Registration : 2014-12-08
A Ramosetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ramosetron, including repackagers and relabelers. The FDA regulates Ramosetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ramosetron 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 Ramosetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ramosetron supplier is an individual or a company that provides Ramosetron active pharmaceutical ingredient (API) or Ramosetron finished formulations upon request. The Ramosetron suppliers may include Ramosetron API manufacturers, exporters, distributors and traders.
click here to find a list of Ramosetron 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 Ramosetron Drug Master File in Japan (Ramosetron JDMF) empowers Ramosetron 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 Ramosetron JDMF during the approval evaluation for pharmaceutical products. At the time of Ramosetron 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 Ramosetron suppliers with JDMF on PharmaCompass.
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