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
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-05
Pay. Date : 2023-12-22
DMF Number : 36535
Submission : 2022-01-05
Status :
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 :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15469
Submission : 2001-06-04
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-17
Pay. Date : 2017-07-31
DMF Number : 19119
Submission : 2006-01-16
Status :
Type : II
A Fenofibric Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenofibric Acid, including repackagers and relabelers. The FDA regulates Fenofibric Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenofibric Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Fenofibric Acid supplier is an individual or a company that provides Fenofibric Acid active pharmaceutical ingredient (API) or Fenofibric Acid finished formulations upon request. The Fenofibric Acid suppliers may include Fenofibric Acid API manufacturers, exporters, distributors and traders.
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A Fenofibric Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenofibric Acid active pharmaceutical ingredient (API) in detail. Different forms of Fenofibric Acid DMFs exist exist since differing nations have different regulations, such as Fenofibric Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenofibric Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Fenofibric Acid USDMF includes data on Fenofibric Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenofibric Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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