Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
01 1Cohance Lifesciences
02 1Glochem Industries
03 1Par Pharmaceutical
04 1Piramal Enterprises Limited
05 1TopChem Pharmaceuticals
01 2TOLCAPONE
02 2TOLCAPONE USP
03 1TOLCAPONE, USP
01 3India
02 1Ireland
03 1U.S.A
01 5Active
01 3Complete
02 2Blank
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-07-10
Pay. Date : 2015-06-02
DMF Number : 28734
Submission : 2014-10-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-15
Pay. Date : 2016-09-20
DMF Number : 30498
Submission : 2016-07-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25857
Submission : 2012-06-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24989
Submission : 2011-05-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-15
Pay. Date : 2014-06-11
DMF Number : 28308
Submission : 2014-06-17
Status : Active
Type : II
A Tolcapone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolcapone, including repackagers and relabelers. The FDA regulates Tolcapone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolcapone 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 Tolcapone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tolcapone supplier is an individual or a company that provides Tolcapone active pharmaceutical ingredient (API) or Tolcapone finished formulations upon request. The Tolcapone suppliers may include Tolcapone API manufacturers, exporters, distributors and traders.
click here to find a list of Tolcapone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tolcapone DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolcapone active pharmaceutical ingredient (API) in detail. Different forms of Tolcapone DMFs exist exist since differing nations have different regulations, such as Tolcapone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tolcapone DMF submitted to regulatory agencies in the US is known as a USDMF. Tolcapone USDMF includes data on Tolcapone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolcapone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tolcapone suppliers with USDMF on PharmaCompass.
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