01 1EISAI PHARMACEUTICALS INDIA PVT LTD
02 1Sanyo Chemical Research Institute Co., Ltd.
03 1Zhejiang Ausun Pharmaceutical Co. , Ltd.
01 3Ramelteon
01 1China
02 1Gabon
03 1Japan
Registration Number : 305MF10035
Registrant's Address : Ramky Pharma City (SEZ), Plot Nos. 96,97,98,124 & 126, Parawada-531 019, Visakhapatna...
Initial Date of Registration : 2023-03-23
Latest Date of Registration : 2023-03-23
Registration Number : 303MF10101
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2021-07-06
Latest Date of Registration : 2024-02-14
Registration Number : 303MF10095
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...
Initial Date of Registration : 2021-06-15
Latest Date of Registration : 2021-06-15
A Ramelteon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ramelteon, including repackagers and relabelers. The FDA regulates Ramelteon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ramelteon 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 Ramelteon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ramelteon supplier is an individual or a company that provides Ramelteon active pharmaceutical ingredient (API) or Ramelteon finished formulations upon request. The Ramelteon suppliers may include Ramelteon API manufacturers, exporters, distributors and traders.
click here to find a list of Ramelteon 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 Ramelteon Drug Master File in Japan (Ramelteon JDMF) empowers Ramelteon 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 Ramelteon JDMF during the approval evaluation for pharmaceutical products. At the time of Ramelteon 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 Ramelteon suppliers with JDMF on PharmaCompass.
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