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 Hydrochloride 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 Hydrochloride manufacturer or Sotalol Hydrochloride supplier for your needs.
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PharmaCompass also assists you with knowing the Sotalol Hydrochloride API Price utilized in the formulation of products. Sotalol Hydrochloride API Price is not always fixed or binding as the Sotalol Hydrochloride Price is obtained through a variety of data sources. The Sotalol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex, including repackagers and relabelers. The FDA regulates Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex supplier is an individual or a company that provides Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex active pharmaceutical ingredient (API) or Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex finished formulations upon request. The Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex suppliers may include Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex API manufacturers, exporters, distributors and traders.
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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, Betapace, Betapace AF, Berlex Laboratories, Sotalex Drug Master File in Japan (Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex JDMF) empowers Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex 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, Betapace, Betapace AF, Berlex Laboratories, Sotalex JDMF during the approval evaluation for pharmaceutical products. At the time of Sotalol hydrochloride, Betapace, Betapace AF, Berlex Laboratories, Sotalex JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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