01 1Agno Pharma
02 1Aurore Life Sciences
03 1F.I.S. Fabbrica Italiana Sintetici
04 1Flamma SpA
05 1JIANGSU ZW PHARMACEUTICALS CO LTD
06 1Nippon Kayaku
07 1Piramal Pharma Solutions
08 1Sifavitor srl
09 4Blank
01 9SULINDAC
02 1SULINDAC USP
03 1SULINDAC USP XXI
04 1Sulindac USP BP-EP, Non-Sterile Drug Substance
01 1China
02 1India
03 3Italy
04 1Japan
05 2U.S.A
06 4Blank
01 5Active
02 7Inactive
01 1Complete
02 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36760
Submission : 2022-02-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-27
Pay. Date : 2017-10-04
DMF Number : 6187
Submission : 1986-02-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21102
Submission : 2007-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7064
Submission : 1987-06-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26004
Submission : 2012-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12224
Submission : 1996-11-15
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8934
Submission : 1990-10-31
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8472
Submission : 1990-03-12
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7005
Submission : 1987-05-29
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6439
Submission : 1986-06-23
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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.
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.
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