01 1ERCROS S. A.
01 1Erythromycin ethyl succinate
01 1Spain
Registration Number : 225MF10104
Registrant's Address : Paseo del Deleite, s/n 28300-Aranjuez, Madrid Spain
Initial Date of Registration : 2013-05-15
Latest Date of Registration : 2021-05-13
A Erythromycin Ethyl Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erythromycin Ethyl Succinate, including repackagers and relabelers. The FDA regulates Erythromycin Ethyl Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erythromycin Ethyl Succinate 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 Erythromycin Ethyl Succinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Erythromycin Ethyl Succinate supplier is an individual or a company that provides Erythromycin Ethyl Succinate active pharmaceutical ingredient (API) or Erythromycin Ethyl Succinate finished formulations upon request. The Erythromycin Ethyl Succinate suppliers may include Erythromycin Ethyl Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Erythromycin Ethyl Succinate 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 Erythromycin Ethyl Succinate Drug Master File in Japan (Erythromycin Ethyl Succinate JDMF) empowers Erythromycin Ethyl Succinate 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 Erythromycin Ethyl Succinate JDMF during the approval evaluation for pharmaceutical products. At the time of Erythromycin Ethyl Succinate 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 Erythromycin Ethyl Succinate suppliers with JDMF on PharmaCompass.
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