01 1CADILA PHARMACEUTICALS LIMITED.
02 1URQUIMA S. A.
01 1Rupatadine fumarate (for manufacturing purposes only)
02 1Rupatajinfumaru salt
01 1India
02 1Spain
Rupatadine fumarate (for manufacturing purposes only)
Registration Number : 306MF10071
Registrant's Address : Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, Gujarat, INDIA
Initial Date of Registration : 2024-05-29
Latest Date of Registration : 2024-05-29
Registration Number : 228MF10183
Registrant's Address : Poli(´)gon Industrial Riera de Caldes Avinguda Cami(´) Reial 51-57 08184 Palau-Soli...
Initial Date of Registration : 2016-09-09
Latest Date of Registration : 2017-06-30
A Rinialer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rinialer, including repackagers and relabelers. The FDA regulates Rinialer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rinialer 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 Rinialer manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rinialer supplier is an individual or a company that provides Rinialer active pharmaceutical ingredient (API) or Rinialer finished formulations upon request. The Rinialer suppliers may include Rinialer API manufacturers, exporters, distributors and traders.
click here to find a list of Rinialer 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 Rinialer Drug Master File in Japan (Rinialer JDMF) empowers Rinialer 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 Rinialer JDMF during the approval evaluation for pharmaceutical products. At the time of Rinialer 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 Rinialer suppliers with JDMF on PharmaCompass.
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