01 1ERCROS S. A.
01 1Erythromycin stearate
01 1Spain
Registration Number : 225MF10103
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 Stearate 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 Stearate manufacturer or Erythromycin Stearate supplier for your needs.
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A Erythromycin stearate [BAN:JAN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erythromycin stearate [BAN:JAN], including repackagers and relabelers. The FDA regulates Erythromycin stearate [BAN:JAN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erythromycin stearate [BAN:JAN] 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 stearate [BAN:JAN] supplier is an individual or a company that provides Erythromycin stearate [BAN:JAN] active pharmaceutical ingredient (API) or Erythromycin stearate [BAN:JAN] finished formulations upon request. The Erythromycin stearate [BAN:JAN] suppliers may include Erythromycin stearate [BAN:JAN] 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 stearate [BAN:JAN] Drug Master File in Japan (Erythromycin stearate [BAN:JAN] JDMF) empowers Erythromycin stearate [BAN:JAN] 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 stearate [BAN:JAN] JDMF during the approval evaluation for pharmaceutical products. At the time of Erythromycin stearate [BAN:JAN] 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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