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
24
PharmaCompass offers a list of Idelalisib 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 Idelalisib manufacturer or Idelalisib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Idelalisib manufacturer or Idelalisib supplier.
PharmaCompass also assists you with knowing the Idelalisib API Price utilized in the formulation of products. Idelalisib API Price is not always fixed or binding as the Idelalisib Price is obtained through a variety of data sources. The Idelalisib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Zydelig manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zydelig, including repackagers and relabelers. The FDA regulates Zydelig manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zydelig 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 Zydelig manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zydelig supplier is an individual or a company that provides Zydelig active pharmaceutical ingredient (API) or Zydelig finished formulations upon request. The Zydelig suppliers may include Zydelig API manufacturers, exporters, distributors and traders.
click here to find a list of Zydelig suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zydelig DMF (Drug Master File) is a document detailing the whole manufacturing process of Zydelig active pharmaceutical ingredient (API) in detail. Different forms of Zydelig DMFs exist exist since differing nations have different regulations, such as Zydelig USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zydelig DMF submitted to regulatory agencies in the US is known as a USDMF. Zydelig USDMF includes data on Zydelig's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zydelig USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zydelig suppliers with USDMF on PharmaCompass.
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