01 1F. I. S. Fabrica Italiana Sintetici S. p. A.
01 1Sulindac
01 1Italy
Registration Number : 220MF10202
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2008-09-19
Latest Date of Registration : 2022-02-10
A Arthrocine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arthrocine, including repackagers and relabelers. The FDA regulates Arthrocine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arthrocine 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 Arthrocine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Arthrocine supplier is an individual or a company that provides Arthrocine active pharmaceutical ingredient (API) or Arthrocine finished formulations upon request. The Arthrocine suppliers may include Arthrocine API manufacturers, exporters, distributors and traders.
click here to find a list of Arthrocine 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 Arthrocine Drug Master File in Japan (Arthrocine JDMF) empowers Arthrocine 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 Arthrocine JDMF during the approval evaluation for pharmaceutical products. At the time of Arthrocine 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 Arthrocine suppliers with JDMF on PharmaCompass.
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