Suanfarma, at the Core of a Better Life.
01 1CIPAN-Companhia Industrial Produtora de Antibioticos, S. A.
02 1Curia Italy S. r. l.
03 1HOVIONE FARMACIENCIA SA
01 2Minocycline Hydrochloride
02 1Minocycline hydrochloride
01 1Portugal
02 1Spain
03 1U.S.A
Suanfarma, at the Core of a Better Life.
Registration Number : 304MF10123
Registrant's Address : Rua da Estacao, 1 e 1A, 2600-726 Castanheira do Ribatejo, Portugal
Initial Date of Registration : 2022-08-17
Latest Date of Registration : 2022-08-17
Registration Number : 217MF10699
Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2020-01-31
Registration Number : 219MF10124
Registrant's Address : Sete Casas 2674-506 Loures PORTUGAL
Initial Date of Registration : 2007-04-18
Latest Date of Registration : 2017-12-06
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A Solodyn manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solodyn, including repackagers and relabelers. The FDA regulates Solodyn manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solodyn API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Solodyn supplier is an individual or a company that provides Solodyn active pharmaceutical ingredient (API) or Solodyn finished formulations upon request. The Solodyn suppliers may include Solodyn API manufacturers, exporters, distributors and traders.
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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 Solodyn Drug Master File in Japan (Solodyn JDMF) empowers Solodyn 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 Solodyn JDMF during the approval evaluation for pharmaceutical products. At the time of Solodyn JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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