01 1Patheon Austria GmbH & Co KG
01 1Neostigmine Bromide
01 1U.S.A
Registration Number : 306MF10020
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2024-01-30
Latest Date of Registration : 2024-01-30
A Neostigmine Bromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neostigmine Bromide, including repackagers and relabelers. The FDA regulates Neostigmine Bromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neostigmine Bromide 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 Neostigmine Bromide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Neostigmine Bromide supplier is an individual or a company that provides Neostigmine Bromide active pharmaceutical ingredient (API) or Neostigmine Bromide finished formulations upon request. The Neostigmine Bromide suppliers may include Neostigmine Bromide API manufacturers, exporters, distributors and traders.
click here to find a list of Neostigmine Bromide 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 Neostigmine Bromide Drug Master File in Japan (Neostigmine Bromide JDMF) empowers Neostigmine Bromide 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 Neostigmine Bromide JDMF during the approval evaluation for pharmaceutical products. At the time of Neostigmine Bromide 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 Neostigmine Bromide suppliers with JDMF on PharmaCompass.
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