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
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PharmaCompass offers a list of Erythromycin Ethyl Succinate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Erythromycin Ethyl Succinate manufacturer or Erythromycin Ethyl Succinate supplier for your needs.
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PharmaCompass also assists you with knowing the Erythromycin Ethyl Succinate API Price utilized in the formulation of products. Erythromycin Ethyl Succinate API Price is not always fixed or binding as the Erythromycin Ethyl Succinate Price is obtained through a variety of data sources. The Erythromycin Ethyl Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Erythromycin Ethylsuccinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erythromycin Ethylsuccinate, including repackagers and relabelers. The FDA regulates Erythromycin Ethylsuccinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erythromycin Ethylsuccinate 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 Erythromycin Ethylsuccinate supplier is an individual or a company that provides Erythromycin Ethylsuccinate active pharmaceutical ingredient (API) or Erythromycin Ethylsuccinate finished formulations upon request. The Erythromycin Ethylsuccinate suppliers may include Erythromycin Ethylsuccinate 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 Erythromycin Ethylsuccinate Drug Master File in Japan (Erythromycin Ethylsuccinate JDMF) empowers Erythromycin Ethylsuccinate 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 Ethylsuccinate JDMF during the approval evaluation for pharmaceutical products. At the time of Erythromycin Ethylsuccinate 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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