01 1Lundbeck Pharmaceuticals Italy S. p. A
01 1Indomethacin sodium
01 1Denmark
Registration Number : 227MF10093
Registrant's Address : Via Quarta Strada, 2 Padova, Italy
Initial Date of Registration : 2015-03-12
Latest Date of Registration : 2015-03-12
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PharmaCompass offers a list of Indomethacin Sodium 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 Indomethacin Sodium manufacturer or Indomethacin Sodium supplier for your needs.
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A Indomethacin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indomethacin Sodium, including repackagers and relabelers. The FDA regulates Indomethacin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indomethacin Sodium 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 Indomethacin Sodium supplier is an individual or a company that provides Indomethacin Sodium active pharmaceutical ingredient (API) or Indomethacin Sodium finished formulations upon request. The Indomethacin Sodium suppliers may include Indomethacin Sodium 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 Indomethacin Sodium Drug Master File in Japan (Indomethacin Sodium JDMF) empowers Indomethacin Sodium 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 Indomethacin Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Indomethacin Sodium 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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