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 Lutetium-177 Vipivotide Tetraxetan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lutetium-177 Vipivotide Tetraxetan, including repackagers and relabelers. The FDA regulates Lutetium-177 Vipivotide Tetraxetan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lutetium-177 Vipivotide Tetraxetan 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 Lutetium-177 Vipivotide Tetraxetan supplier is an individual or a company that provides Lutetium-177 Vipivotide Tetraxetan active pharmaceutical ingredient (API) or Lutetium-177 Vipivotide Tetraxetan finished formulations upon request. The Lutetium-177 Vipivotide Tetraxetan suppliers may include Lutetium-177 Vipivotide Tetraxetan 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 Lutetium-177 Vipivotide Tetraxetan Drug Master File in Japan (Lutetium-177 Vipivotide Tetraxetan JDMF) empowers Lutetium-177 Vipivotide Tetraxetan 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 Lutetium-177 Vipivotide Tetraxetan JDMF during the approval evaluation for pharmaceutical products. At the time of Lutetium-177 Vipivotide Tetraxetan 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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