01 2Centrient Pharmaceuticals Spain S. A.
01 1Japanese Pharmacopoeia cephalexin
02 1Purilex (Cefalexin Monohydrate)
01 2Netherlands
Purilex (Cefalexin Monohydrate)
Registration Number : 304MF10144
Registrant's Address : C/ Ripolles 2, Santa Perpetua de Mogoda, 08130 Barcelona, Spain
Initial Date of Registration : 2022-10-26
Latest Date of Registration : 2025-02-07
Japanese Pharmacopoeia Cephalexin
Registration Number : 218MF10199
Registrant's Address : C/ Ripolles 2, Santa Perpetua de Mogoda, 08130 Barcelona, Spain
Initial Date of Registration : 2006-02-08
Latest Date of Registration : 2025-02-07
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PharmaCompass offers a list of Cephalexin Monohydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Cephalexin Monohydrate manufacturer or Cephalexin Monohydrate supplier for your needs.
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A cefalexin monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of cefalexin monohydrate, including repackagers and relabelers. The FDA regulates cefalexin monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. cefalexin monohydrate 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 cefalexin monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A cefalexin monohydrate supplier is an individual or a company that provides cefalexin monohydrate active pharmaceutical ingredient (API) or cefalexin monohydrate finished formulations upon request. The cefalexin monohydrate suppliers may include cefalexin monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of cefalexin monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 cefalexin monohydrate Drug Master File in Japan (cefalexin monohydrate JDMF) empowers cefalexin monohydrate 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 cefalexin monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of cefalexin monohydrate 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 cefalexin monohydrate suppliers with JDMF on PharmaCompass.
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