01 1Hetero Drugs
02 1MSN Laboratories
01 1BOSUTINIB MONOHYDRATE
02 1BOSUTINIB MONOHYDRATE (FORM-I)
01 2India
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39380
Submission : 2024-05-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30683
Submission : 2016-07-08
Status : Active
Type : II
A Bosutinib Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bosutinib Monohydrate, including repackagers and relabelers. The FDA regulates Bosutinib Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bosutinib Monohydrate 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 Bosutinib Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bosutinib Monohydrate supplier is an individual or a company that provides Bosutinib Monohydrate active pharmaceutical ingredient (API) or Bosutinib Monohydrate finished formulations upon request. The Bosutinib Monohydrate suppliers may include Bosutinib Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Bosutinib Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bosutinib Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bosutinib Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Bosutinib Monohydrate DMFs exist exist since differing nations have different regulations, such as Bosutinib Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bosutinib Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Bosutinib Monohydrate USDMF includes data on Bosutinib Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bosutinib Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bosutinib Monohydrate suppliers with USDMF on PharmaCompass.
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