01 1DYNAMIT NOBEL GmbH
01 1Ciclesonide
01 1Germany
Registration Number : 220MF10193
Registrant's Address : Kalkstrasse 218, 51377 Leverkusen, Germany
Initial Date of Registration : 2008-08-28
Latest Date of Registration : 2023-10-04
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PharmaCompass offers a list of Ciclesonide 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 Ciclesonide manufacturer or Ciclesonide supplier for your needs.
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A Omnaris manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omnaris, including repackagers and relabelers. The FDA regulates Omnaris manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omnaris 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 Omnaris manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Omnaris supplier is an individual or a company that provides Omnaris active pharmaceutical ingredient (API) or Omnaris finished formulations upon request. The Omnaris suppliers may include Omnaris API manufacturers, exporters, distributors and traders.
click here to find a list of Omnaris 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 Omnaris Drug Master File in Japan (Omnaris JDMF) empowers Omnaris 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 Omnaris JDMF during the approval evaluation for pharmaceutical products. At the time of Omnaris 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 Omnaris suppliers with JDMF on PharmaCompass.
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