01 1Alembic Pharmaceuticals Limited
02 1Hetero Drugs
03 1MSN Laboratories
01 3India
01 2Active
02 1Blank
01 3Blank
01 3Blank
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30683
Submission : 2016-07-08
Status : Active
Type : II
NDC Package Code : 54893-0048
Start Marketing Date : 2016-06-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39380
Submission : 2024-05-09
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.
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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.
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