01 1Patheon Austria GmbH & Co KG
01 1Paciromer Sorbitex Calcium
01 1U.S.A
Registration Number : 305MF10083
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2023-07-19
Latest Date of Registration : 2023-07-19
A Patiromer Sorbitex Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Patiromer Sorbitex Calcium, including repackagers and relabelers. The FDA regulates Patiromer Sorbitex Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Patiromer Sorbitex Calcium supplier is an individual or a company that provides Patiromer Sorbitex Calcium active pharmaceutical ingredient (API) or Patiromer Sorbitex Calcium finished formulations upon request. The Patiromer Sorbitex Calcium suppliers may include Patiromer Sorbitex Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium Drug Master File in Japan (Patiromer Sorbitex Calcium JDMF) empowers Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium JDMF during the approval evaluation for pharmaceutical products. At the time of Patiromer Sorbitex Calcium 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 Patiromer Sorbitex Calcium suppliers with JDMF on PharmaCompass.
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