Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
01 1Aarti Pharmalabs
02 1Alembic Pharmaceuticals Limited
03 2Cipla
04 3MSN Laboratories
05 1Natco Pharma
01 3ACALABRUTINIB
02 1ACALABRUTINIB DIHYDRATE
03 2ACALABRUTINIB MALEATE
04 1ACALABRUTINIB [ROUTE CODE HU]
05 1BENZYL(2S)-2-(8-AMINO-1-BROMOIMIDAZO[1,5-A]PYRAZIN-3-YL)PYRROLIDINE-1-CARBOXYLATE(VP-023)
01 8India
01 8Active
01 6Complete
02 2Blank
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35796
Submission : 2021-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-30
Pay. Date : 2021-06-18
DMF Number : 36029
Submission : 2021-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-03
Pay. Date : 2021-04-16
DMF Number : 35762
Submission : 2021-05-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-30
Pay. Date : 2023-09-22
DMF Number : 38325
Submission : 2023-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-09
Pay. Date : 2021-05-25
DMF Number : 35558
Submission : 2021-02-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-06-25
Pay. Date : 2024-06-07
DMF Number : 39468
Submission : 2024-03-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35757
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-13
Pay. Date : 2021-09-20
DMF Number : 36263
Submission : 2021-09-15
Status : Active
Type : II
A Acalabrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acalabrutinib, including repackagers and relabelers. The FDA regulates Acalabrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acalabrutinib 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 Acalabrutinib supplier is an individual or a company that provides Acalabrutinib active pharmaceutical ingredient (API) or Acalabrutinib finished formulations upon request. The Acalabrutinib suppliers may include Acalabrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Acalabrutinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acalabrutinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Acalabrutinib active pharmaceutical ingredient (API) in detail. Different forms of Acalabrutinib DMFs exist exist since differing nations have different regulations, such as Acalabrutinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acalabrutinib DMF submitted to regulatory agencies in the US is known as a USDMF. Acalabrutinib USDMF includes data on Acalabrutinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acalabrutinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
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