01 1CARBOGEN AMCIS AG
01 1Nepafenac
01 1Switzerland
Registration Number : 222MF10160
Registrant's Address : Hauptstrasse 171, CH-4416 Bubendorf, Switzerland
Initial Date of Registration : 2010-05-31
Latest Date of Registration : 2010-05-31
A Nepafenac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nepafenac, including repackagers and relabelers. The FDA regulates Nepafenac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nepafenac 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 Nepafenac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nepafenac supplier is an individual or a company that provides Nepafenac active pharmaceutical ingredient (API) or Nepafenac finished formulations upon request. The Nepafenac suppliers may include Nepafenac API manufacturers, exporters, distributors and traders.
click here to find a list of Nepafenac 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 Nepafenac Drug Master File in Japan (Nepafenac JDMF) empowers Nepafenac 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 Nepafenac JDMF during the approval evaluation for pharmaceutical products. At the time of Nepafenac 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 Nepafenac suppliers with JDMF on PharmaCompass.
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