01 1Derivados Quimicos sau
02 1FINORGA S. A. S.
03 1Olon S. p. A.
01 1BETAXOLOL HYDROCHLORIDE
02 1Betaxolol Hydrochloride
03 1Betaxolol hydrochloride
01 1Gabon
02 1Italy
03 1Spain
Registration Number : 305MF10078
Registrant's Address : Camino de Pliego, No. 150, Alcantarilla, 30820, Murcia, Spain
Initial Date of Registration : 2023-07-12
Latest Date of Registration : 2023-07-12
Registration Number : 218MF10546
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2006-06-02
Latest Date of Registration : 2024-08-07
Registration Number : 219MF10314
Registrant's Address : Route de Givors-B. P. 9-38670 Chasse sur Rho(＾)ne-France
Initial Date of Registration : 2007-10-05
Latest Date of Registration : 2007-10-05
A Betaxolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betaxolol, including repackagers and relabelers. The FDA regulates Betaxolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betaxolol 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 Betaxolol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betaxolol supplier is an individual or a company that provides Betaxolol active pharmaceutical ingredient (API) or Betaxolol finished formulations upon request. The Betaxolol suppliers may include Betaxolol API manufacturers, exporters, distributors and traders.
click here to find a list of Betaxolol 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 Betaxolol Drug Master File in Japan (Betaxolol JDMF) empowers Betaxolol 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 Betaxolol JDMF during the approval evaluation for pharmaceutical products. At the time of Betaxolol 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 Betaxolol suppliers with JDMF on PharmaCompass.
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