01 1Alembic Pharmaceuticals Limited
02 1Teva Pharmaceutical Industries
01 2IVOSIDENIB
01 1India
02 1Israel
01 2Active
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
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.
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