01 1Aurore Life Sciences
02 1CSPC Pharmaceutical Group
03 1Chemi SpA
04 1EURAND INC
05 1Esteve Quimica
06 1F.I.S. Fabbrica Italiana Sintetici
07 1Genus Lifesciences
08 1Hetero Drugs
09 1Industriale Chimica
10 1Macleods Pharmaceuticals Limited
11 1SIGMA TAU
12 2Blank
01 9INDOMETHACIN
02 1INDOMETHACIN FOR HUMAN USE
03 1INDOMETHACIN USP
04 1INDOMETHACINE USP XX
05 1TIVORBEX (INDOMETHACIN) CAPSULES
01 1China
02 3India
03 3Italy
04 1Spain
05 3U.S.A
06 2Blank
01 5Active
02 8Inactive
01 4Complete
02 9Blank
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-11
Pay. Date : 2022-03-31
DMF Number : 36761
Submission : 2022-02-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4394
Submission : 1982-01-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21984
Submission : 2008-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4220
Submission : 1981-03-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5978
Submission : 1985-08-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-07
DMF Number : 3136
Submission : 1978-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-22
Pay. Date : 2021-10-21
DMF Number : 36364
Submission : 2021-10-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2633
Submission : 1976-03-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-27
Pay. Date : 2021-07-08
DMF Number : 21740
Submission : 2008-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5258
Submission : 1983-07-20
Status : Inactive
Type : II
A Indomethacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indomethacin, including repackagers and relabelers. The FDA regulates Indomethacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indomethacin 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 Indomethacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indomethacin supplier is an individual or a company that provides Indomethacin active pharmaceutical ingredient (API) or Indomethacin finished formulations upon request. The Indomethacin suppliers may include Indomethacin API manufacturers, exporters, distributors and traders.
click here to find a list of Indomethacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indomethacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Indomethacin active pharmaceutical ingredient (API) in detail. Different forms of Indomethacin DMFs exist exist since differing nations have different regulations, such as Indomethacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indomethacin DMF submitted to regulatory agencies in the US is known as a USDMF. Indomethacin USDMF includes data on Indomethacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indomethacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indomethacin suppliers with USDMF on PharmaCompass.
We have 11 companies offering Indomethacin
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?