Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1TAPI Technology & API Services
03 1Beijing Sjar Technology Development
04 2MSN Laboratories
05 1Olon S.p.A
01 1China
02 2India
03 1Israel
04 1Italy
05 1Spain
01 3Active
02 3Blank
01 6Blank
01 6Blank
01 6Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-08-08
Pay. Date : 2023-05-30
DMF Number : 38215
Submission : 2023-03-31
Status : Active
Type : II
NDC Package Code : 54893-0502
Start Marketing Date : 2023-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39665
Submission : 2024-03-27
Status : Active
Type : II
NDC Package Code : 54893-0502
Start Marketing Date : 2023-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-27
Pay. Date : 2023-05-10
DMF Number : 38350
Submission : 2023-05-12
Status : Active
Type : II
NDC Package Code : 17337-0321
Start Marketing Date : 2023-03-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
We have 5 companies offering (R)-Zanubrutinib
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