01 1RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S. P. A.
01 1Cysteamine Hydrochloride
01 1Italy
Registration Number : 305MF10060
Registrant's Address : VIA M. Civitali, 1-20148 MILANO, ITALY
Initial Date of Registration : 2023-05-17
Latest Date of Registration : 2024-02-07
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PharmaCompass offers a list of Cysteamine 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 Cysteamine Hydrochloride manufacturer or Cysteamine Hydrochloride supplier for your needs.
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PharmaCompass also assists you with knowing the Cysteamine Hydrochloride API Price utilized in the formulation of products. Cysteamine Hydrochloride API Price is not always fixed or binding as the Cysteamine Hydrochloride Price is obtained through a variety of data sources. The Cysteamine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 2-aminoethyl mercaptan hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-aminoethyl mercaptan hydrochloride, including repackagers and relabelers. The FDA regulates 2-aminoethyl mercaptan hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-aminoethyl mercaptan 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.
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A 2-aminoethyl mercaptan hydrochloride supplier is an individual or a company that provides 2-aminoethyl mercaptan hydrochloride active pharmaceutical ingredient (API) or 2-aminoethyl mercaptan hydrochloride finished formulations upon request. The 2-aminoethyl mercaptan hydrochloride suppliers may include 2-aminoethyl mercaptan hydrochloride 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 2-aminoethyl mercaptan hydrochloride Drug Master File in Japan (2-aminoethyl mercaptan hydrochloride JDMF) empowers 2-aminoethyl mercaptan 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 2-aminoethyl mercaptan hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of 2-aminoethyl mercaptan hydrochloride 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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