With Fermion, start the journey of your innovative API.
01 1Fermion Oy
02 1Arevipharma
03 1Cipla
04 1Curia
05 1Gedeon Richter
06 1Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. CN 223 002 Huai'an
07 3Blank
01 7FLUTAMIDE
02 2FLUTAMIDE USP
01 1China
02 1Finland
03 1Germany
04 1Hungary
05 1India
06 1U.S.A
07 3Blank
01 2Active
02 7Inactive
01 9Blank
With Fermion, start the journey of your innovative API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11522
Submission : 1995-05-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23507
Submission : 2010-01-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14637
Submission : 1999-12-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12807
Submission : 1997-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10497
Submission : 1993-09-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19951
Submission : 2006-11-02
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14719
Submission : 2000-02-18
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 : 12790
Submission : 1997-12-11
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 : 4144
Submission : 1981-04-16
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Odyne manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Odyne, including repackagers and relabelers. The FDA regulates Odyne manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Odyne 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 Odyne manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Odyne supplier is an individual or a company that provides Odyne active pharmaceutical ingredient (API) or Odyne finished formulations upon request. The Odyne suppliers may include Odyne API manufacturers, exporters, distributors and traders.
click here to find a list of Odyne suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Odyne DMF (Drug Master File) is a document detailing the whole manufacturing process of Odyne active pharmaceutical ingredient (API) in detail. Different forms of Odyne DMFs exist exist since differing nations have different regulations, such as Odyne USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Odyne DMF submitted to regulatory agencies in the US is known as a USDMF. Odyne USDMF includes data on Odyne's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Odyne USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Odyne suppliers with USDMF on PharmaCompass.
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