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
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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ponatinib manufacturer or Ponatinib supplier.
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 Ponatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ponatinib, including repackagers and relabelers. The FDA regulates Ponatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ponatinib 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 Ponatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ponatinib supplier is an individual or a company that provides Ponatinib active pharmaceutical ingredient (API) or Ponatinib finished formulations upon request. The Ponatinib suppliers may include Ponatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Ponatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ponatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ponatinib active pharmaceutical ingredient (API) in detail. Different forms of Ponatinib DMFs exist exist since differing nations have different regulations, such as Ponatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ponatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Ponatinib USDMF includes data on Ponatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ponatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ponatinib suppliers with USDMF on PharmaCompass.
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