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List of Drug Master Files (DMF) of Sulindac Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Piramal Pharma Solutions (1)

02 Agno Pharma (1)

03 Aurore Life Sciences (1)

04 Dipharma (1)

05 F.I.S. Fabbrica Italiana Sintetici (1)

06 Flamma SpA (1)

07 JIANGSU ZW PHARMACEUTICALS CO LTD (1)

08 Nippon Kayaku (1)

09 Sifavitor srl (1)

10 Blank (4)

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01 SULINDAC (9)

02 SULINDAC USP (1)

03 SULINDAC USP XXI (1)

04 SULINDAC, MANFACTURED IN MERETO DI TOMBA (UD), ITALY (1)

05 Sulindac USP BP-EP, Non-Sterile Drug Substance (1)

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01 China (1)

02 India (1)

03 Italy (4)

04 Japan (1)

05 U.S.A (2)

06 Blank (4)

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01 Active (5)

02 Inactive (8)

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01 Complete (1)

02 Blank (12)

URL Supplier Web Content
26004
Active
2012-04-20
N/A
II
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36760
Active
2022-02-03
N/A
II
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URL Supplier Web Content
6187
Active
1986-02-11
Complete
2017-10-27
2017-10-04
II
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URL Supplier Web Content
21102
Active
2007-11-28
N/A
II
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URL Supplier Web Content
7064
Inactive
1987-06-22
N/A
II
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URL Supplier Web Content
12224
Active
1996-11-15
N/A
II
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SIBEFAT SPA

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7005
Inactive
1987-05-29
N/A
II
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SIBEFAT SRL

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8934
Inactive
1990-10-31
N/A
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DINAMITE DIPHARMA SPA

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6439
Inactive
1986-06-23
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SUMIKA FINE CHEMICALS CO LTD

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8472
Inactive
1990-03-12
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Looking for 38194-50-2 / Sulindac API manufacturers, exporters & distributors?

Sulindac manufacturers, exporters & distributors 1

15

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 USDMF

A Sulindac DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulindac active pharmaceutical ingredient (API) in detail. Different forms of Sulindac DMFs exist exist since differing nations have different regulations, such as Sulindac USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Sulindac DMF submitted to regulatory agencies in the US is known as a USDMF. Sulindac USDMF includes data on Sulindac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulindac USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Sulindac suppliers with USDMF on PharmaCompass.

Sulindac Manufacturers | Traders | Suppliers

Sulindac Manufacturers, Traders, Suppliers 1
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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