01 1Alembic Pharmaceuticals Limited
02 1Hetero Drugs
03 1MSN Laboratories
04 1ScinoPharm Taiwan, Ltd
01 4OSIMERTINIB MESYLATE
01 3India
02 1Taiwan
01 4Active
01 2Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-26
Pay. Date : 2018-12-12
DMF Number : 33409
Submission : 2018-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35581
Submission : 2021-02-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-06
Pay. Date : 2019-03-14
DMF Number : 32143
Submission : 2017-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36546
Submission : 2021-12-24
Status : Active
Type : II
A Osimertinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Osimertinib, including repackagers and relabelers. The FDA regulates Osimertinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Osimertinib 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 Osimertinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Osimertinib supplier is an individual or a company that provides Osimertinib active pharmaceutical ingredient (API) or Osimertinib finished formulations upon request. The Osimertinib suppliers may include Osimertinib API manufacturers, exporters, distributors and traders.
click here to find a list of Osimertinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Osimertinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Osimertinib active pharmaceutical ingredient (API) in detail. Different forms of Osimertinib DMFs exist exist since differing nations have different regulations, such as Osimertinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Osimertinib DMF submitted to regulatory agencies in the US is known as a USDMF. Osimertinib USDMF includes data on Osimertinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Osimertinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Osimertinib suppliers with USDMF on PharmaCompass.
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