01 1Shionogi Pharma Co., Ltd.
01 1Lobatirelin hydrate
01 1Japan
Registration Number : 303MF10165
Registrant's Address : 2-5-1 Mishima, Settsu City, Osaka Prefecture
Initial Date of Registration : 2021-11-25
Latest Date of Registration : 2021-11-25
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PharmaCompass offers a list of Rovatirelin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Rovatirelin manufacturer or Rovatirelin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rovatirelin manufacturer or Rovatirelin supplier.
PharmaCompass also assists you with knowing the Rovatirelin API Price utilized in the formulation of products. Rovatirelin API Price is not always fixed or binding as the Rovatirelin Price is obtained through a variety of data sources. The Rovatirelin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rovatirelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rovatirelin, including repackagers and relabelers. The FDA regulates Rovatirelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rovatirelin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Rovatirelin supplier is an individual or a company that provides Rovatirelin active pharmaceutical ingredient (API) or Rovatirelin finished formulations upon request. The Rovatirelin suppliers may include Rovatirelin API manufacturers, exporters, distributors and traders.
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 Rovatirelin Drug Master File in Japan (Rovatirelin JDMF) empowers Rovatirelin 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 Rovatirelin JDMF during the approval evaluation for pharmaceutical products. At the time of Rovatirelin 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 Rovatirelin suppliers with JDMF on PharmaCompass.
