With Fermion, start the journey of your innovative API.
01 1Fermion Oy
02 1Cohance Lifesciences
03 1Neuland Laboratories
04 1Arch Pharmalabs
05 1Aurobindo Pharma Limited
06 1Dipharma
07 1Erregierre SpA
08 1F.I.S. Fabbrica Italiana Sintetici
09 1HEC Pharm
10 1Hetero Drugs
11 1Jubilant Generics
12 1Macleods Pharmaceuticals Limited
13 1Piramal Pharma Solutions
14 1RANBAXY LABORATORIES LIMITED
15 1Standard Chem. & Pharm. Co., Ltd
16 1Sun Pharmaceutical Industries Limited
17 2Suven Life Sciences Limited
18 1Wockhardt
01 13ENTACAPONE
02 1ENTACAPONE NON-STERILE BULK DRUG SUBSTANCE
03 3ENTACAPONE USP
04 1ENTACAPONE USP (FORM-A)
05 1ENTACAPONE USP (NON-STERILE DRUG SUBSTANCE)
01 2China
02 1Finland
03 12India
04 3Italy
05 1U.S.A
01 15Active
02 4Inactive
01 6Complete
02 13Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12444
Submission : 1997-03-26
Status : Active
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-24
Pay. Date : 2015-09-29
DMF Number : 23937
Submission : 2010-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-02-22
DMF Number : 21526
Submission : 2008-04-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24188
Submission : 2010-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22538
Submission : 2009-02-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23984
Submission : 2010-07-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24361
Submission : 2010-12-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20326
Submission : 2007-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19092
Submission : 2006-01-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19385
Submission : 2006-03-01
Status : Active
Type : II
A Entacapone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entacapone, including repackagers and relabelers. The FDA regulates Entacapone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entacapone 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 Entacapone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Entacapone supplier is an individual or a company that provides Entacapone active pharmaceutical ingredient (API) or Entacapone finished formulations upon request. The Entacapone suppliers may include Entacapone API manufacturers, exporters, distributors and traders.
click here to find a list of Entacapone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Entacapone DMF (Drug Master File) is a document detailing the whole manufacturing process of Entacapone active pharmaceutical ingredient (API) in detail. Different forms of Entacapone DMFs exist exist since differing nations have different regulations, such as Entacapone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Entacapone DMF submitted to regulatory agencies in the US is known as a USDMF. Entacapone USDMF includes data on Entacapone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Entacapone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Entacapone suppliers with USDMF on PharmaCompass.
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