01 1Cambrex Profarmaco Milano S. r. l.
01 1Erythromycin lactobionate
01 1U.S.A
Registration Number : 219MF10321
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2007-10-24
Latest Date of Registration : 2024-05-15
A Erythromycin Lactobionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erythromycin Lactobionate, including repackagers and relabelers. The FDA regulates Erythromycin Lactobionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erythromycin Lactobionate 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 Lactobionate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Erythromycin Lactobionate supplier is an individual or a company that provides Erythromycin Lactobionate active pharmaceutical ingredient (API) or Erythromycin Lactobionate finished formulations upon request. The Erythromycin Lactobionate suppliers may include Erythromycin Lactobionate API manufacturers, exporters, distributors and traders.
click here to find a list of Erythromycin Lactobionate 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 Lactobionate Drug Master File in Japan (Erythromycin Lactobionate JDMF) empowers Erythromycin Lactobionate 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 Lactobionate JDMF during the approval evaluation for pharmaceutical products. At the time of Erythromycin Lactobionate 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 Lactobionate suppliers with JDMF on PharmaCompass.
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