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
A Cysteamine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cysteamine Hydrochloride, including repackagers and relabelers. The FDA regulates Cysteamine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cysteamine 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 Cysteamine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cysteamine Hydrochloride supplier is an individual or a company that provides Cysteamine Hydrochloride active pharmaceutical ingredient (API) or Cysteamine Hydrochloride finished formulations upon request. The Cysteamine Hydrochloride suppliers may include Cysteamine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cysteamine 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 Cysteamine Hydrochloride Drug Master File in Japan (Cysteamine Hydrochloride JDMF) empowers Cysteamine 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 Cysteamine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Cysteamine 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 Cysteamine Hydrochloride suppliers with JDMF on PharmaCompass.
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