01 1S. I. M. S. S. r. l.
01 1Outsiders regulations tetrahydrozoline hydrochloride (production only)
01 1Italy
Tetrahydrozoline hydrochloride (for manufacturing purposes only)
Registration Number : 218MF10080
Registrant's Address : 50066 Reggello (Firenze) Italy
Initial Date of Registration : 2006-01-27
Latest Date of Registration : 2010-03-23
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A Visine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Visine, including repackagers and relabelers. The FDA regulates Visine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Visine 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 Visine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Visine supplier is an individual or a company that provides Visine active pharmaceutical ingredient (API) or Visine finished formulations upon request. The Visine suppliers may include Visine 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 Visine Drug Master File in Japan (Visine JDMF) empowers Visine 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 Visine JDMF during the approval evaluation for pharmaceutical products. At the time of Visine 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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