01 1MSN Laboratories
02 1Signa S.A. de C.V.
03 1Viatris
01 3PONATINIB HYDROCHLORIDE
01 1India
02 1Mexico
03 1U.S.A
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37854
Submission : 2022-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-29
Pay. Date : 2020-11-27
DMF Number : 35413
Submission : 2020-12-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-07-22
Pay. Date : 2022-06-06
DMF Number : 32340
Submission : 2018-01-07
Status : Active
Type : II
21
PharmaCompass offers a list of Ponatinib 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 Ponatinib manufacturer or Ponatinib supplier for your needs.
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PharmaCompass also assists you with knowing the Ponatinib API Price utilized in the formulation of products. Ponatinib API Price is not always fixed or binding as the Ponatinib Price is obtained through a variety of data sources. The Ponatinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Iclusig manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iclusig, including repackagers and relabelers. The FDA regulates Iclusig manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iclusig 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 Iclusig manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iclusig supplier is an individual or a company that provides Iclusig active pharmaceutical ingredient (API) or Iclusig finished formulations upon request. The Iclusig suppliers may include Iclusig API manufacturers, exporters, distributors and traders.
click here to find a list of Iclusig suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iclusig DMF (Drug Master File) is a document detailing the whole manufacturing process of Iclusig active pharmaceutical ingredient (API) in detail. Different forms of Iclusig DMFs exist exist since differing nations have different regulations, such as Iclusig USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iclusig DMF submitted to regulatory agencies in the US is known as a USDMF. Iclusig USDMF includes data on Iclusig's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iclusig USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iclusig suppliers with USDMF on PharmaCompass.
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