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
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PharmaCompass also assists you with knowing the Erythromycin Lactobionate API Price utilized in the formulation of products. Erythromycin Lactobionate API Price is not always fixed or binding as the Erythromycin Lactobionate Price is obtained through a variety of data sources. The Erythromycin Lactobionate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A C37H67NO13.C12H22O12 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C37H67NO13.C12H22O12, including repackagers and relabelers. The FDA regulates C37H67NO13.C12H22O12 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 supplier is an individual or a company that provides C37H67NO13.C12H22O12 active pharmaceutical ingredient (API) or C37H67NO13.C12H22O12 finished formulations upon request. The C37H67NO13.C12H22O12 suppliers may include C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 Drug Master File in Japan (C37H67NO13.C12H22O12 JDMF) empowers C37H67NO13.C12H22O12 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 C37H67NO13.C12H22O12 JDMF during the approval evaluation for pharmaceutical products. At the time of C37H67NO13.C12H22O12 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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