01 2Loba biotech GmbH
01 2Naphazoline Nitrate (for manufacturing only)
01 2Austria
Naphazoline nitrate (for manufacturing only)
Registration Number : 221MF10084
Registrant's Address : Fehrgasse 7 A-2401 Fischamend, Austria
Initial Date of Registration : 2009-04-22
Latest Date of Registration : 2018-09-14
Naphazoline nitrate (for manufacturing only)
Registration Number : 231MF10042
Registrant's Address : Fehrgasse 7 A-2401 Fischamend, Austria
Initial Date of Registration : 2019-02-13
Latest Date of Registration : 2019-02-13
A Naphazoline Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naphazoline Nitrate, including repackagers and relabelers. The FDA regulates Naphazoline Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naphazoline Nitrate 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 Naphazoline Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naphazoline Nitrate supplier is an individual or a company that provides Naphazoline Nitrate active pharmaceutical ingredient (API) or Naphazoline Nitrate finished formulations upon request. The Naphazoline Nitrate suppliers may include Naphazoline Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Naphazoline Nitrate 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 Naphazoline Nitrate Drug Master File in Japan (Naphazoline Nitrate JDMF) empowers Naphazoline Nitrate 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 Naphazoline Nitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Naphazoline Nitrate 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 Naphazoline Nitrate suppliers with JDMF on PharmaCompass.
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