01 1Cambrex Profarmaco Milano S. r. l.
01 1Sotalol Hydrochloride
01 1U.S.A
Registration Number : 302MF10102
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2020-08-18
Latest Date of Registration : 2021-05-10
A Sotalol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sotalol Hydrochloride, including repackagers and relabelers. The FDA regulates Sotalol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sotalol Hydrochloride 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 Sotalol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sotalol Hydrochloride supplier is an individual or a company that provides Sotalol Hydrochloride active pharmaceutical ingredient (API) or Sotalol Hydrochloride finished formulations upon request. The Sotalol Hydrochloride suppliers may include Sotalol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sotalol Hydrochloride 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 Sotalol Hydrochloride Drug Master File in Japan (Sotalol Hydrochloride JDMF) empowers Sotalol Hydrochloride 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 Sotalol Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Sotalol Hydrochloride 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 Sotalol Hydrochloride suppliers with JDMF on PharmaCompass.
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