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List of Drug Master Files (DMF) of Acalabrutinib Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Aarti Pharmalabs (1)

02 Alembic Pharmaceuticals Limited (1)

03 Cipla (2)

04 MSN Laboratories (2)

05 Natco Pharma (1)

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01 ACALABRUTINIB (3)

02 ACALABRUTINIB DIHYDRATE (1)

03 ACALABRUTINIB MALEATE (1)

04 ACALABRUTINIB [ROUTE CODE HU] (1)

05 BENZYL(2S)-2-(8-AMINO-1-BROMOIMIDAZO[1,5-A]PYRAZIN-3-YL)PYRROLIDINE-1-CARBOXYLATE(VP-023) (1)

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01 India (7)

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01 Active (7)

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01 Complete (5)

02 Blank (2)

URL Supplier Web Content
36029
Active
2021-06-30
Complete
2021-08-30
2021-06-18
II
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URL Supplier Web Content
38325
Active
2023-07-14
Complete
2023-10-30
2023-09-22
II
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URL Supplier Web Content
35762
Active
2021-05-03
Complete
2021-06-03
2021-04-16
II
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URL Supplier Web Content
35757
Active
2021-03-29
N/A
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URL Supplier Web Content
35558
Active
2021-02-01
Complete
2021-07-09
2021-05-25
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URL Supplier Web Content
36263
Active
2021-09-15
Complete
2021-10-13
2021-09-20
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Looking for 1420477-60-6 / Acalabrutinib API manufacturers, exporters & distributors?

Acalabrutinib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Acalabrutinib 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 Acalabrutinib manufacturer or Acalabrutinib supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acalabrutinib manufacturer or Acalabrutinib supplier.

PharmaCompass also assists you with knowing the Acalabrutinib API Price utilized in the formulation of products. Acalabrutinib API Price is not always fixed or binding as the Acalabrutinib Price is obtained through a variety of data sources. The Acalabrutinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Acalabrutinib

Synonyms

1420477-60-6, Acp-196, Calquence, Acalabrutinib (acp-196), Acalabrutinib [inn], I42748elqw

Cas Number

1420477-60-6

Unique Ingredient Identifier (UNII)

I42748ELQW

About Acalabrutinib

Acalabrutinib is an orally available inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon administration, acalabrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. This prevents both B-cell activation and BTK-mediated activation of downstream survival pathways. This leads to an inhibition of the growth of malignant B cells that overexpress BTK. BTK, a member of the src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed in B-cell malignancies; it plays an important role in B lymphocyte development, activation, signaling, proliferation and survival.

Acalabrutinib Manufacturers

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.

click here to find a list of Acalabrutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Acalabrutinib Suppliers

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.

Acalabrutinib USDMF

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.

click here to find a list of Acalabrutinib suppliers with USDMF on PharmaCompass.

Acalabrutinib Manufacturers | Traders | Suppliers

Acalabrutinib Manufacturers, Traders, Suppliers 1
78

We have 5 companies offering Acalabrutinib

Get in contact with the supplier of your choice:

  1. Aarti Pharmalabs
  2. Alembic Pharmaceuticals Limited
  3. Cipla
  4. MSN Laboratories
  5. Natco Pharma
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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