PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
01 1PMC ISOCHEM
02 1Cambrex Profarmaco Milano S. r. l.
01 1Amiodarone Hydrochloride
02 1Hydrochloric acid amiodarone
01 1France
02 1U.S.A
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
Registration Number : 226MF10094
Registrant's Address : 32 Rue Lavoisier 91710 Vert-Le-Petit, France
Initial Date of Registration : 2014-05-14
Latest Date of Registration : 2022-03-02
Registration Number : 218MF10853
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2006-10-20
Latest Date of Registration : 2021-04-08
A Amiodarone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amiodarone, including repackagers and relabelers. The FDA regulates Amiodarone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amiodarone 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 Amiodarone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amiodarone supplier is an individual or a company that provides Amiodarone active pharmaceutical ingredient (API) or Amiodarone finished formulations upon request. The Amiodarone suppliers may include Amiodarone API manufacturers, exporters, distributors and traders.
click here to find a list of Amiodarone 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 Amiodarone Drug Master File in Japan (Amiodarone JDMF) empowers Amiodarone 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 Amiodarone JDMF during the approval evaluation for pharmaceutical products. At the time of Amiodarone 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 Amiodarone suppliers with JDMF on PharmaCompass.
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