Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
01 1Cohance Lifesciences
02 1Neuland Laboratories
03 1ALP Pharm
04 1APOTECNIA SA
05 1Glenmark Life Sciences
06 1Grace
07 1Hetero Drugs
08 1Johnson & Johnson Innovative Medicine
09 1Murli Krishna Pharma
10 1Piramal Enterprises Limited
11 2Quimica Sintetica
12 1SIMS Srl
13 1SMS Pharmaceuticals
14 1Vasudha Pharma Chem
15 1Viatris
01 6ITRACONAZOLE
02 1ITRACONAZOLE (DRUG SUBSTANCE, NON-STERILE)
03 1ITRACONAZOLE (R051211) DRUG SUBSTANCE
04 1ITRACONAZOLE PELLETS 22.0 % W/W
05 6ITRACONAZOLE USP
06 1ITRACONAZOLE USP & PH EUR
01 1China
02 1France
03 8India
04 1Italy
05 2Spain
06 3U.S.A
01 10Active
02 6Inactive
01 6Complete
02 10Blank
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-19
Pay. Date : 2013-03-11
DMF Number : 25986
Submission : 2012-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-12
Pay. Date : 2013-06-19
DMF Number : 15445
Submission : 2001-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17946
Submission : 2004-12-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-08
Pay. Date : 2017-12-28
DMF Number : 12697
Submission : 1997-10-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10725
Submission : 1994-02-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27410
Submission : 2013-08-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-31
Pay. Date : 2013-10-07
DMF Number : 13012
Submission : 1998-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-08
Pay. Date : 2013-08-13
DMF Number : 25514
Submission : 2011-11-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35261
Submission : 2020-10-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-27
Pay. Date : 2013-02-06
DMF Number : 17739
Submission : 2004-10-08
Status : Active
Type : II
A Itraconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Itraconazole, including repackagers and relabelers. The FDA regulates Itraconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Itraconazole 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 Itraconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Itraconazole supplier is an individual or a company that provides Itraconazole active pharmaceutical ingredient (API) or Itraconazole finished formulations upon request. The Itraconazole suppliers may include Itraconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Itraconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Itraconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Itraconazole active pharmaceutical ingredient (API) in detail. Different forms of Itraconazole DMFs exist exist since differing nations have different regulations, such as Itraconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Itraconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Itraconazole USDMF includes data on Itraconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Itraconazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Itraconazole suppliers with USDMF on PharmaCompass.
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