IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
01 1IOL Chemicals and Pharmaceuticals
02 1Seqens
03 2Moehs Iberica
04 1AXYNTIS Group
05 2Alembic Pharmaceuticals Limited
06 1Amsa Spa
07 1CordenPharma
08 2DK Pharmachem Pvt. Ltd
09 1Derivados Quimicos SAU
10 1Harman Finochem
11 1Hetero Drugs
12 1Ipca Laboratories
13 1Jiangsu Nhwa Pharmaceutical
14 1Laboratorio Chimico Internazionale Spa
15 2Lupin Ltd
16 1Olon S.p.A
17 1Smruthi Organics
18 1Unichem Laboratories Limited
19 1Zhejiang Yongtai Technology
20 4Blank
01 9FENOFIBRATE
02 1FENOFIBRATE (PROCETOFEN)
03 1FENOFIBRATE CAPSULES
04 1FENOFIBRATE DRUG SUBSTANCE
05 1FENOFIBRATE SPRAY GRANULATION INTERMEDIATE
06 9FENOFIBRATE USP
07 1FENOFIBRATE USP (PROCESS B)
08 1FENOFIBRATE, USP
09 1FENOFIBRATE-SLS MIXTURE
10 1FENOFIBRIC ACID CHOLINE SALT
11 1MICRONIZED FENOFIBRATE & FENOFIBRATE
01 2China
02 2France
03 1Germany
04 12India
05 3Italy
06 3Spain
07 4Blank
01 16Active
02 11Inactive
01 11Complete
02 16Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-05
Pay. Date : 2023-12-22
DMF Number : 36535
Submission : 2022-01-05
Status : Active
Type : II
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 : 11194
Submission : 1994-11-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15469
Submission : 2001-06-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-17
Pay. Date : 2017-07-31
DMF Number : 19119
Submission : 2006-01-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-31
Pay. Date : 2014-03-24
DMF Number : 23047
Submission : 2009-08-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-05
DMF Number : 16208
Submission : 2002-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12078
Submission : 1996-08-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13801
Submission : 1998-10-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2016-11-14
DMF Number : 21551
Submission : 2008-04-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-27
Pay. Date : 2016-05-13
DMF Number : 15438
Submission : 2001-05-08
Status : Active
Type : II
A Fenofibrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenofibrate, including repackagers and relabelers. The FDA regulates Fenofibrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenofibrate 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 Fenofibrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fenofibrate supplier is an individual or a company that provides Fenofibrate active pharmaceutical ingredient (API) or Fenofibrate finished formulations upon request. The Fenofibrate suppliers may include Fenofibrate API manufacturers, exporters, distributors and traders.
click here to find a list of Fenofibrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fenofibrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenofibrate active pharmaceutical ingredient (API) in detail. Different forms of Fenofibrate DMFs exist exist since differing nations have different regulations, such as Fenofibrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenofibrate DMF submitted to regulatory agencies in the US is known as a USDMF. Fenofibrate USDMF includes data on Fenofibrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenofibrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fenofibrate suppliers with USDMF on PharmaCompass.
We have 19 companies offering Fenofibrate
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