01 1MSN Laboratories
02 1Teva Pharmaceutical Industries
01 1TUCATINIB
02 1TUCATINIB HEMIETHANOLATE
01 1India
02 1Israel
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-13
Pay. Date : 2024-02-13
DMF Number : 39450
Submission : 2024-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39057
Submission : 2023-10-26
Status : Active
Type : II
A Tucatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tucatinib, including repackagers and relabelers. The FDA regulates Tucatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tucatinib 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 Tucatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tucatinib supplier is an individual or a company that provides Tucatinib active pharmaceutical ingredient (API) or Tucatinib finished formulations upon request. The Tucatinib suppliers may include Tucatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Tucatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tucatinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Tucatinib active pharmaceutical ingredient (API) in detail. Different forms of Tucatinib DMFs exist exist since differing nations have different regulations, such as Tucatinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tucatinib DMF submitted to regulatory agencies in the US is known as a USDMF. Tucatinib USDMF includes data on Tucatinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tucatinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tucatinib suppliers with USDMF on PharmaCompass.
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