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01 1Alembic Pharmaceuticals Limited
02 1Hetero Drugs
03 1MSN Laboratories
04 1ScinoPharm Taiwan Ltd
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01 4OSIMERTINIB MESYLATE
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01 3India
02 1Taiwan
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01 4Active
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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
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PharmaCompass offers a list of Osimertinib Mesylate 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 Osimertinib Mesylate manufacturer or Osimertinib Mesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Osimertinib Mesylate manufacturer or Osimertinib Mesylate supplier.
PharmaCompass also assists you with knowing the Osimertinib Mesylate API Price utilized in the formulation of products. Osimertinib Mesylate API Price is not always fixed or binding as the Osimertinib Mesylate Price is obtained through a variety of data sources. The Osimertinib Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TAGRISSO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TAGRISSO, including repackagers and relabelers. The FDA regulates TAGRISSO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TAGRISSO 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 TAGRISSO manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TAGRISSO supplier is an individual or a company that provides TAGRISSO active pharmaceutical ingredient (API) or TAGRISSO finished formulations upon request. The TAGRISSO suppliers may include TAGRISSO API manufacturers, exporters, distributors and traders.
click here to find a list of TAGRISSO suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TAGRISSO DMF (Drug Master File) is a document detailing the whole manufacturing process of TAGRISSO active pharmaceutical ingredient (API) in detail. Different forms of TAGRISSO DMFs exist exist since differing nations have different regulations, such as TAGRISSO USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TAGRISSO DMF submitted to regulatory agencies in the US is known as a USDMF. TAGRISSO USDMF includes data on TAGRISSO's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TAGRISSO USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TAGRISSO suppliers with USDMF on PharmaCompass.
We have 4 companies offering TAGRISSO
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