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List of Drug Master Files (KDMF) for Calquence Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Dottikon Exclusive Synthesis AG (2)

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01 AstraZeneca Korea Co., Ltd. (2)

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01 Acalabrutinib (1)

02 Acalabrutinib maleate monohydrate (1)

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01 Switzerland (2)

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AstraZeneca Korea Co., Ltd.
2023-02-25
Wed248-19-ND
Dottikon Exclusive Synthe...
Switzerland
Hembrunnstrasse 17, 5605 ...
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URL Supplier Web Content
AstraZeneca Korea Co., Ltd.
2021-02-05
Wed248-15-ND
Dottikon Exclusive Synthe...
Switzerland
Hembrunnstrasse 17, 5605 ...
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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.

Calquence Manufacturers

A Calquence manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calquence, including repackagers and relabelers. The FDA regulates Calquence manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calquence 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 Calquence manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Calquence Suppliers

A Calquence supplier is an individual or a company that provides Calquence active pharmaceutical ingredient (API) or Calquence finished formulations upon request. The Calquence suppliers may include Calquence API manufacturers, exporters, distributors and traders.

click here to find a list of Calquence suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Calquence KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Calquence Drug Master File in Korea (Calquence KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calquence. The MFDS reviews the Calquence KDMF as part of the drug registration process and uses the information provided in the Calquence KDMF to evaluate the safety and efficacy of the drug.

After submitting a Calquence KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Calquence API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Calquence suppliers with KDMF on PharmaCompass.

Calquence Manufacturers | Traders | Suppliers

Calquence Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Calquence

Get in contact with the supplier of your choice:

  1. DOTTIKON EXCLUSIVE SYNTHESIS AG
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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