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01 1Hetero Drugs
02 1MSN Laboratories
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01 1BOSUTINIB MONOHYDRATE
02 1BOSUTINIB MONOHYDRATE (FORM-I)
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01 2India
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01 2Active
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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
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PharmaCompass offers a list of Bosutinib Monohydrate 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 Bosutinib Monohydrate manufacturer or Bosutinib Monohydrate supplier for your needs.
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A 918639-08-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 918639-08-4, including repackagers and relabelers. The FDA regulates 918639-08-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 918639-08-4 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 918639-08-4 supplier is an individual or a company that provides 918639-08-4 active pharmaceutical ingredient (API) or 918639-08-4 finished formulations upon request. The 918639-08-4 suppliers may include 918639-08-4 API manufacturers, exporters, distributors and traders.
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A 918639-08-4 DMF (Drug Master File) is a document detailing the whole manufacturing process of 918639-08-4 active pharmaceutical ingredient (API) in detail. Different forms of 918639-08-4 DMFs exist exist since differing nations have different regulations, such as 918639-08-4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 918639-08-4 DMF submitted to regulatory agencies in the US is known as a USDMF. 918639-08-4 USDMF includes data on 918639-08-4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 918639-08-4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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