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01 2EUROAPI FRANCE
02 1STEROID S. p. A.
01 1Dexamethasone meth sulfobenzoic acid ester sodium
02 1Dexamethasone phosphate ester sodium
03 1Japanese Pharmaceutical Codex dexamethasone meth sulfobenzoic acid ester sodium (manufactured only)
01 2France
02 1Italy
Dexamethasone sodium phosphate
Registration Number : 222MF10092
Registrant's Address : 15 rue Traversie(')re 75012 Paris France
Initial Date of Registration : 2010-03-17
Latest Date of Registration : 2020-09-14
Dexamethasone metasulfobenzoate sodium
Registration Number : 222MF10093
Registrant's Address : 15 rue Traversie(')re 75012 Paris France
Initial Date of Registration : 2010-03-17
Latest Date of Registration : 2016-03-07
Registration Number : 221MF10245
Registrant's Address : Viale Spagna, 156 Cologno Monzese (MI) - ITALY
Initial Date of Registration : 2009-11-16
Latest Date of Registration : 2009-11-16
A Dexamethasone Sodium Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexamethasone Sodium Phosphate, including repackagers and relabelers. The FDA regulates Dexamethasone Sodium Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexamethasone Sodium Phosphate supplier is an individual or a company that provides Dexamethasone Sodium Phosphate active pharmaceutical ingredient (API) or Dexamethasone Sodium Phosphate finished formulations upon request. The Dexamethasone Sodium Phosphate suppliers may include Dexamethasone Sodium Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate Drug Master File in Japan (Dexamethasone Sodium Phosphate JDMF) empowers Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate suppliers with JDMF on PharmaCompass.
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