01 2MSN Laboratories
02 1Olon S.p.A
01 2ZANUBRUTINIB
02 1ZANUBRUTINIB (FORM-A)
01 2India
02 1Italy
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-08
Pay. Date : 2023-05-30
DMF Number : 38215
Submission : 2023-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39665
Submission : 2024-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-27
Pay. Date : 2023-05-10
DMF Number : 38350
Submission : 2023-05-12
Status : Active
Type : II
A (R)-Zanubrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (R)-Zanubrutinib, including repackagers and relabelers. The FDA regulates (R)-Zanubrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (R)-Zanubrutinib 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 (R)-Zanubrutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (R)-Zanubrutinib supplier is an individual or a company that provides (R)-Zanubrutinib active pharmaceutical ingredient (API) or (R)-Zanubrutinib finished formulations upon request. The (R)-Zanubrutinib suppliers may include (R)-Zanubrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of (R)-Zanubrutinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (R)-Zanubrutinib DMF (Drug Master File) is a document detailing the whole manufacturing process of (R)-Zanubrutinib active pharmaceutical ingredient (API) in detail. Different forms of (R)-Zanubrutinib DMFs exist exist since differing nations have different regulations, such as (R)-Zanubrutinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (R)-Zanubrutinib DMF submitted to regulatory agencies in the US is known as a USDMF. (R)-Zanubrutinib USDMF includes data on (R)-Zanubrutinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (R)-Zanubrutinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of (R)-Zanubrutinib suppliers with USDMF on PharmaCompass.
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