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List of Drug Master Files (JDMF) for Sulindac Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 F. I. S. Fabrica Italiana Sintetici S. p. A. (1)

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01 Sulindac (1)

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01 Italy (1)

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220MF10202
Viale Milano 26 36075 Montecchio Ma...
2022-02-10
2008-09-19
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Looking for 38194-50-2 / Sulindac API manufacturers, exporters & distributors?

Sulindac manufacturers, exporters & distributors 1

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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.

API | Excipient name

Sulindac

Synonyms

Clinoril, 38194-50-2, Arthrocine, Artribid, Sulindaco, Sulindacum

Cas Number

38194-50-2

Unique Ingredient Identifier (UNII)

184SNS8VUH

About Sulindac

A sulfinylindene derivative prodrug whose sulfinyl moiety is converted in vivo to an active NSAID analgesic. Specifically, the prodrug is converted by liver enzymes to a sulfide which is excreted in the bile and then reabsorbed from the intestine. This helps to maintain constant blood levels with reduced gastrointestinal side effects.

Sulindac Manufacturers

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.

Sulindac Suppliers

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.

Sulindac JDMF

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.

Sulindac Manufacturers | Traders | Suppliers

Sulindac Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Sulindac

Get in contact with the supplier of your choice:

  1. F.I.S. Fabbrica Italiana Sintetici
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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