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
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PharmaCompass offers a list of Sulindac 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 Sulindac manufacturer or Sulindac supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulindac manufacturer or Sulindac supplier.
PharmaCompass also assists you with knowing the Sulindac API Price utilized in the formulation of products. Sulindac API Price is not always fixed or binding as the Sulindac Price is obtained through a variety of data sources. The Sulindac Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sulindac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulindac, including repackagers and relabelers. The FDA regulates Sulindac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulindac 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 Sulindac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulindac supplier is an individual or a company that provides Sulindac active pharmaceutical ingredient (API) or Sulindac finished formulations upon request. The Sulindac suppliers may include Sulindac API manufacturers, exporters, distributors and traders.
click here to find a list of Sulindac 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 Sulindac Drug Master File in Japan (Sulindac JDMF) empowers Sulindac 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 Sulindac JDMF during the approval evaluation for pharmaceutical products. At the time of Sulindac 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 Sulindac suppliers with JDMF on PharmaCompass.
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