01 1Lupin Ltd
02 1Natco Pharma
03 1Zhejiang Lepu Pharmaceutical
01 2IDELALISIB
02 1IDELALISIB NON-STERILE BULK DRUG SUBSTANCES
01 1China
02 2India
01 2Active
02 1Inactive
01 2Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32434
Submission : 2018-01-23
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-30
Pay. Date : 2021-11-16
DMF Number : 36371
Submission : 2021-11-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-16
Pay. Date : 2018-03-23
DMF Number : 32519
Submission : 2018-03-20
Status : Active
Type : II
A Idelalisib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Idelalisib, including repackagers and relabelers. The FDA regulates Idelalisib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Idelalisib 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 Idelalisib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Idelalisib supplier is an individual or a company that provides Idelalisib active pharmaceutical ingredient (API) or Idelalisib finished formulations upon request. The Idelalisib suppliers may include Idelalisib API manufacturers, exporters, distributors and traders.
click here to find a list of Idelalisib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Idelalisib DMF (Drug Master File) is a document detailing the whole manufacturing process of Idelalisib active pharmaceutical ingredient (API) in detail. Different forms of Idelalisib DMFs exist exist since differing nations have different regulations, such as Idelalisib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Idelalisib DMF submitted to regulatory agencies in the US is known as a USDMF. Idelalisib USDMF includes data on Idelalisib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Idelalisib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Idelalisib suppliers with USDMF on PharmaCompass.
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