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