Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
01 1Seqens
02 1TAPI Technology & API Services
03 1Alembic Pharmaceuticals Limited
04 1Amino Chemicals
05 1Aurobindo Pharma Limited
06 1CEPHALON INC
07 1Chromo Laboratories
08 1Dipharma
09 1Flamma SpA
10 1Helsinn Advanced Synthesis
11 1Orchid Pharma
12 1Sun Pharmaceutical Industries Limited
13 1Symed Labs
14 1UQUIFA
15 1Viatris
01 1(R)-MODAFINIL
02 7MODAFINIL
03 1MODAFINIL DRUG SUBSTANCE
04 5MODAFINIL USP
05 1MODAFINIL USP (NON-STERILE DRUG SUBSTANCE)
01 1France
02 6India
03 1Israel
04 2Italy
05 1Malta
06 1Spain
07 1Switzerland
08 2U.S.A
01 10Active
02 5Inactive
01 3Complete
02 12Blank
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16140
Submission : 2002-09-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16310
Submission : 2002-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16477
Submission : 2003-03-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-29
Pay. Date : 2013-09-23
DMF Number : 23898
Submission : 2010-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11970
Submission : 1996-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36975
Submission : 2022-04-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-07-05
DMF Number : 16250
Submission : 2002-11-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19645
Submission : 2006-08-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-16
Pay. Date : 2024-01-09
DMF Number : 38533
Submission : 2023-12-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16306
Submission : 2002-12-12
Status : Active
Type : II
A Modafinil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Modafinil, including repackagers and relabelers. The FDA regulates Modafinil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Modafinil 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 Modafinil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Modafinil supplier is an individual or a company that provides Modafinil active pharmaceutical ingredient (API) or Modafinil finished formulations upon request. The Modafinil suppliers may include Modafinil API manufacturers, exporters, distributors and traders.
click here to find a list of Modafinil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Modafinil DMF (Drug Master File) is a document detailing the whole manufacturing process of Modafinil active pharmaceutical ingredient (API) in detail. Different forms of Modafinil DMFs exist exist since differing nations have different regulations, such as Modafinil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Modafinil DMF submitted to regulatory agencies in the US is known as a USDMF. Modafinil USDMF includes data on Modafinil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Modafinil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Modafinil suppliers with USDMF on PharmaCompass.
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