01 1piCHEM Forschungs- und Entwicklungs GmbH
01 1Bipibotide tetraxetane
01 1Austria
Registration Number : 306MF10140
Registrant's Address : Parkring 3, 8074 Raaba-Grambach, Austria
Initial Date of Registration : 2024-11-06
Latest Date of Registration : 2024-11-06
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PharmaCompass offers a list of Lutetium-177 Vipivotide Tetraxetan 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 Lutetium-177 Vipivotide Tetraxetan manufacturer or Lutetium-177 Vipivotide Tetraxetan supplier for your needs.
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A 177 Lu-Labeled Psma-617 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 177 Lu-Labeled Psma-617, including repackagers and relabelers. The FDA regulates 177 Lu-Labeled Psma-617 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 177 Lu-Labeled Psma-617 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A 177 Lu-Labeled Psma-617 supplier is an individual or a company that provides 177 Lu-Labeled Psma-617 active pharmaceutical ingredient (API) or 177 Lu-Labeled Psma-617 finished formulations upon request. The 177 Lu-Labeled Psma-617 suppliers may include 177 Lu-Labeled Psma-617 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 177 Lu-Labeled Psma-617 Drug Master File in Japan (177 Lu-Labeled Psma-617 JDMF) empowers 177 Lu-Labeled Psma-617 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 177 Lu-Labeled Psma-617 JDMF during the approval evaluation for pharmaceutical products. At the time of 177 Lu-Labeled Psma-617 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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