01 1HAS Healthcare Advanced Synthesis SA
02 1Patheon Austria GmbH & Co KG
01 2Pyridostigmine bromide
01 1Switzerland
02 1U.S.A
Registration Number : 221MF10103
Registrant's Address : Via Industria, 24 6710 Biasca Switzerland
Initial Date of Registration : 2009-05-27
Latest Date of Registration : 2009-05-27
Registration Number : 227MF10212
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2015-08-18
Latest Date of Registration : 2015-08-18
A Pyridostigmine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pyridostigmine, including repackagers and relabelers. The FDA regulates Pyridostigmine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pyridostigmine 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 Pyridostigmine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pyridostigmine supplier is an individual or a company that provides Pyridostigmine active pharmaceutical ingredient (API) or Pyridostigmine finished formulations upon request. The Pyridostigmine suppliers may include Pyridostigmine API manufacturers, exporters, distributors and traders.
click here to find a list of Pyridostigmine 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 Pyridostigmine Drug Master File in Japan (Pyridostigmine JDMF) empowers Pyridostigmine 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 Pyridostigmine JDMF during the approval evaluation for pharmaceutical products. At the time of Pyridostigmine 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 Pyridostigmine suppliers with JDMF on PharmaCompass.
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