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01 1AR Life Sciences
02 1Alembic Pharmaceuticals Limited
03 2Aurobindo Pharma Limited
04 1Cipla
05 1Glenmark Life Sciences
06 1Lupin Ltd
07 1MSN Laboratories
08 1ScinoPharm Taiwan, Ltd
09 1Sun Pharmaceutical Industries Limited
10 2Vindhya Organics
11 1Blank
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01 14-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID [STARTING MATERIAL OF IVACAFTOR]
02 14-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID/IVF-3P
03 1AMINO PHENOL DERIVATIVE [STARTING MATERIAL OF IVACATOR]
04 8IVACAFTOR
05 1IVACAFTOR PREMIX
06 1IVACAFTOR [ROUTE CODE - 'IC']
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01 11India
02 1Taiwan
03 1Blank
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01 13Active
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01 7Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-06-28
DMF Number : 31849
Submission : 2017-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35586
Submission : 2021-02-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-13
Pay. Date : 2021-07-07
DMF Number : 36094
Submission : 2021-07-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-19
Pay. Date : 2015-03-10
DMF Number : 28867
Submission : 2015-03-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-20
Pay. Date : 2020-07-02
DMF Number : 32610
Submission : 2019-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-17
Pay. Date : 2023-08-29
DMF Number : 29398
Submission : 2015-05-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35447
Submission : 2020-12-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-10
Pay. Date : 2019-07-25
DMF Number : 33783
Submission : 2019-07-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35551
Submission : 2021-01-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35587
Submission : 2021-02-09
Status : Active
Type : II
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PharmaCompass offers a list of Ivacaftor API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ivacaftor manufacturer or Ivacaftor supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ivacaftor manufacturer or Ivacaftor supplier.
PharmaCompass also assists you with knowing the Ivacaftor API Price utilized in the formulation of products. Ivacaftor API Price is not always fixed or binding as the Ivacaftor Price is obtained through a variety of data sources. The Ivacaftor Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Kalydeco manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kalydeco, including repackagers and relabelers. The FDA regulates Kalydeco manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kalydeco 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 Kalydeco manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Kalydeco supplier is an individual or a company that provides Kalydeco active pharmaceutical ingredient (API) or Kalydeco finished formulations upon request. The Kalydeco suppliers may include Kalydeco API manufacturers, exporters, distributors and traders.
click here to find a list of Kalydeco suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Kalydeco DMF (Drug Master File) is a document detailing the whole manufacturing process of Kalydeco active pharmaceutical ingredient (API) in detail. Different forms of Kalydeco DMFs exist exist since differing nations have different regulations, such as Kalydeco USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Kalydeco DMF submitted to regulatory agencies in the US is known as a USDMF. Kalydeco USDMF includes data on Kalydeco's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Kalydeco USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Kalydeco suppliers with USDMF on PharmaCompass.
We have 10 companies offering Kalydeco
Get in contact with the supplier of your choice: