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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 39665
Submission : 2024-03-27
Status : Active
Type : II
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 : Complete
Rev. Date : 2023-06-27
Pay. Date : 2023-05-10
DMF Number : 38350
Submission : 2023-05-12
Status : Active
Type : II
48
PharmaCompass offers a list of Zanubrutinib 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 Zanubrutinib manufacturer or Zanubrutinib supplier for your needs.
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PharmaCompass also assists you with knowing the Zanubrutinib API Price utilized in the formulation of products. Zanubrutinib API Price is not always fixed or binding as the Zanubrutinib Price is obtained through a variety of data sources. The Zanubrutinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
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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.
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