Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
01 1CU CHEMIE UETIKON GMBH
01 1Sodium phenylbutyrate
01 1France
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Registration Number : 223MF10149
Registrant's Address : Raiffeisenstrasse 4, D-77933 Lahr Germany
Initial Date of Registration : 2011-10-14
Latest Date of Registration : 2023-11-01
A Sodium Phenylbutyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Phenylbutyrate, including repackagers and relabelers. The FDA regulates Sodium Phenylbutyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Phenylbutyrate 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 Sodium Phenylbutyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Phenylbutyrate supplier is an individual or a company that provides Sodium Phenylbutyrate active pharmaceutical ingredient (API) or Sodium Phenylbutyrate finished formulations upon request. The Sodium Phenylbutyrate suppliers may include Sodium Phenylbutyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Phenylbutyrate 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 Sodium Phenylbutyrate Drug Master File in Japan (Sodium Phenylbutyrate JDMF) empowers Sodium Phenylbutyrate 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 Sodium Phenylbutyrate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Phenylbutyrate 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 Sodium Phenylbutyrate suppliers with JDMF on PharmaCompass.
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