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01 1Alembic Pharmaceuticals Limited
02 1Teva Pharmaceutical Industries
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01 2IVOSIDENIB
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01 1India
02 1Israel
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01 2Active
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01 2Complete
GDUFA
DMF Review : Complete
Rev. Date : 2022-05-11
Pay. Date : 2022-05-04
DMF Number : 36786
Submission : 2022-02-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-02
Pay. Date : 2021-12-14
DMF Number : 36151
Submission : 2022-02-04
Status : Active
Type : II
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PharmaCompass offers a list of Ivosidenib 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 Ivosidenib manufacturer or Ivosidenib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ivosidenib manufacturer or Ivosidenib supplier.
PharmaCompass also assists you with knowing the Ivosidenib API Price utilized in the formulation of products. Ivosidenib API Price is not always fixed or binding as the Ivosidenib Price is obtained through a variety of data sources. The Ivosidenib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ivosidenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivosidenib, including repackagers and relabelers. The FDA regulates Ivosidenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivosidenib 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 Ivosidenib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ivosidenib supplier is an individual or a company that provides Ivosidenib active pharmaceutical ingredient (API) or Ivosidenib finished formulations upon request. The Ivosidenib suppliers may include Ivosidenib API manufacturers, exporters, distributors and traders.
click here to find a list of Ivosidenib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ivosidenib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ivosidenib active pharmaceutical ingredient (API) in detail. Different forms of Ivosidenib DMFs exist exist since differing nations have different regulations, such as Ivosidenib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ivosidenib DMF submitted to regulatory agencies in the US is known as a USDMF. Ivosidenib USDMF includes data on Ivosidenib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ivosidenib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ivosidenib suppliers with USDMF on PharmaCompass.
We have 2 companies offering Ivosidenib
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