01 1Novartis Pharma AG
01 1Pentetreotide
01 1Switzerland
Registration Number : 227MF10097
Registrant's Address : Lichtstrasse 35, CH-4056 Basel, Switzerland
Initial Date of Registration : 2015-04-09
Latest Date of Registration : 2015-04-09
A Pentetreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentetreotide, including repackagers and relabelers. The FDA regulates Pentetreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentetreotide 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 Pentetreotide supplier is an individual or a company that provides Pentetreotide active pharmaceutical ingredient (API) or Pentetreotide finished formulations upon request. The Pentetreotide suppliers may include Pentetreotide API manufacturers, exporters, distributors and traders.
click here to find a list of Pentetreotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Pentetreotide Drug Master File in Japan (Pentetreotide JDMF) empowers Pentetreotide 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 Pentetreotide JDMF during the approval evaluation for pharmaceutical products. At the time of Pentetreotide 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 Pentetreotide suppliers with JDMF on PharmaCompass.
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