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
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PharmaCompass offers a list of SOTALOL HCI API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right SOTALOL HCI manufacturer or SOTALOL HCI supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred SOTALOL HCI manufacturer or SOTALOL HCI supplier.
PharmaCompass also assists you with knowing the SOTALOL HCI API Price utilized in the formulation of products. SOTALOL HCI API Price is not always fixed or binding as the SOTALOL HCI Price is obtained through a variety of data sources. The SOTALOL HCI Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sotalol HCL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sotalol HCL, including repackagers and relabelers. The FDA regulates Sotalol HCL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sotalol HCL 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 HCL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sotalol HCL supplier is an individual or a company that provides Sotalol HCL active pharmaceutical ingredient (API) or Sotalol HCL finished formulations upon request. The Sotalol HCL suppliers may include Sotalol HCL API manufacturers, exporters, distributors and traders.
click here to find a list of Sotalol HCL 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 HCL Drug Master File in Japan (Sotalol HCL JDMF) empowers Sotalol HCL 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 HCL JDMF during the approval evaluation for pharmaceutical products. At the time of Sotalol HCL 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 HCL suppliers with JDMF on PharmaCompass.
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