01 1Fersinsa Gb S. A. de C. V.
01 1Benzylpenicillin Potassium
01 1Netherlands
Registration Number : 229MF10121
Registrant's Address : Carretera Saltillo-Mty km 12.5, Ramos Arizpe, Coahuela 25900, Mexico
Initial Date of Registration : 2017-07-11
Latest Date of Registration : 2018-04-23
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PharmaCompass also assists you with knowing the Benzylpenicillin Sodium API Price utilized in the formulation of products. Benzylpenicillin Sodium API Price is not always fixed or binding as the Benzylpenicillin Sodium Price is obtained through a variety of data sources. The Benzylpenicillin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Penilevel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Penilevel, including repackagers and relabelers. The FDA regulates Penilevel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Penilevel 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 Penilevel supplier is an individual or a company that provides Penilevel active pharmaceutical ingredient (API) or Penilevel finished formulations upon request. The Penilevel suppliers may include Penilevel 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 Penilevel Drug Master File in Japan (Penilevel JDMF) empowers Penilevel 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 Penilevel JDMF during the approval evaluation for pharmaceutical products. At the time of Penilevel 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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