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Chemistry

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Also known as: 1420477-60-6, Acp-196, Calquence, Acalabrutinib (acp-196), Acalabrutinib [inn], I42748elqw
Molecular Formula
C26H23N7O2
Molecular Weight
465.5  g/mol
InChI Key
WDENQIQQYWYTPO-IBGZPJMESA-N
FDA UNII
I42748ELQW

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 is a Kinase Inhibitor. The mechanism of action of acalabrutinib is as a Tyrosine Kinase Inhibitor.
1 2D Structure

Acalabrutinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[8-amino-3-[(2S)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-N-pyridin-2-ylbenzamide
2.1.2 InChI
InChI=1S/C26H23N7O2/c1-2-6-21(34)32-15-5-7-19(32)25-31-22(23-24(27)29-14-16-33(23)25)17-9-11-18(12-10-17)26(35)30-20-8-3-4-13-28-20/h3-4,8-14,16,19H,5,7,15H2,1H3,(H2,27,29)(H,28,30,35)/t19-/m0/s1
2.1.3 InChI Key
WDENQIQQYWYTPO-IBGZPJMESA-N
2.1.4 Canonical SMILES
CC#CC(=O)N1CCCC1C2=NC(=C3N2C=CN=C3N)C4=CC=C(C=C4)C(=O)NC5=CC=CC=N5
2.1.5 Isomeric SMILES
CC#CC(=O)N1CCC[C@H]1C2=NC(=C3N2C=CN=C3N)C4=CC=C(C=C4)C(=O)NC5=CC=CC=N5
2.2 Other Identifiers
2.2.1 UNII
I42748ELQW
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Acp-196

2. Calquence

2.3.2 Depositor-Supplied Synonyms

1. 1420477-60-6

2. Acp-196

3. Calquence

4. Acalabrutinib (acp-196)

5. Acalabrutinib [inn]

6. I42748elqw

7. 4-[8-amino-3-[(2s)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-n-pyridin-2-ylbenzamide

8. Benzamide, 4-(8-amino-3-((2s)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl)imidazo(1,5-a)pyrazin-1-yl)-n-2-pyridinyl-

9. (s)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide

10. Acalabrutinib(acp196)

11. Acalabrutinib [usan:inn]

12. Acalabrutinibum

13. Unii-i42748elqw

14. Calquence (tn)

15. Benzamide, 4-[8-amino-3-[(2s)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl]-n-2-pyridinyl-

16. Acp-196;acalabrutinib

17. Acalabrutinib [mi]

18. Acalabrutinib [jan]

19. Acalabrutinib [usan]

20. Acalabrutinib [who-dd]

21. Gtpl8912

22. Acalabrutinib (jan/usan/inn)

23. Chembl3707348

24. Schembl14637368

25. Acp 196

26. Amy5290

27. Ex-a881

28. Chebi:167707

29. Dtxsid401026209

30. Acalabrutinib [orange Book]

31. Bdbm50175583

32. Mfcd29472294

33. Nsc791164

34. Nsc800976

35. S8116

36. Zinc208774715

37. Ccg-269407

38. Cs-5356

39. Db11703

40. Ds-3326

41. Nsc-791164

42. Nsc-800976

43. Ncgc00479074-01

44. Hy-17600

45. Example 6 [us20140155385 A1]

46. D10893

47. A857446

48. J-690166

49. Q23668732

50. (s)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide;acalabrutinib

51. (s)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide

52. 4-[8-amino-3-[(2s)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl]-n-2-pyridinyl-benzamide

53. 4-[8-amino-3-[(2s)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-n-(2-pyridyl)benzamide

54. 4-{8-amino-3-[(2s)-1-(but-2-ynoyl)pyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl}-n-(pyridin-2-yl)benzamide

2.4 Create Date
2013-03-21
3 Chemical and Physical Properties
Molecular Weight 465.5 g/mol
Molecular Formula C26H23N7O2
XLogP33
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count6
Rotatable Bond Count4
Exact Mass465.19132300 g/mol
Monoisotopic Mass465.19132300 g/mol
Topological Polar Surface Area119 Ų
Heavy Atom Count35
Formal Charge0
Complexity845
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NameCALQUENCE
Active IngredientACALABRUTINIB
CompanyASTRAZENECA (Application Number: N210259. Patents: 9290504, 9758524, 9796721)

4.2 Drug Indication

Acalabrutinib is currently indicated for the treatment of adult patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. It has also been recently approved for chronic lymphocytic leukemia and small lymphocytic lymphoma.


FDA Label


Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Acalabrutinib is a Bruton Tyrosine Kinase inhibitor that prevents the proliferation, trafficking, chemotaxis, and adhesion of B cells. It is taken every 12 hours and can cause other effects such as atrial fibrillation, other malignancies, cytopenia, hemorrhage, and infection.


5.2 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
ACALABRUTINIB
5.3.2 FDA UNII
I42748ELQW
5.3.3 Pharmacological Classes
Tyrosine Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]
5.4 ATC Code

L01XE51


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EL - Bruton's tyrosine kinase (btk) inhibitors

L01EL02 - Acalabrutinib


5.5 Absorption, Distribution and Excretion

Absorption

The geometric mean absolute bioavailability of acalabrutinib is 25% with a median time to peak plasma concentrations (Tmax) of 0.75 hours.


Route of Elimination

After administration of a single 100 mg radiolabelled acalabrutinib dose in healthy subjects, 84% of the dose was recovered in the feces and 12% of the dose was recovered in the urine. An irradiated dose of acalabrutinib was 34.7% recovered as the metabolite ACP-5862; 8.6% was recovered as unchanged acalabrutinub; 10.8 was recovered as a mixture of the M7, M8, M9, M10, and M11 metabolites; 5.9% was the M25 metabolite; 2.5% was recovered as the M3 metabolite.


Volume of Distribution

The mean steady-state volume of distribution is approximately 34 L.


Clearance

Acalabrutinib's mean apparent oral clearance (CL/F) is observed to be 159 L/hr with similar PK between patients and healthy subjects, based on population PK analysis.


5.6 Metabolism/Metabolites

Acalabrutinib is mainly metabolized by CYP3A enzymes. ACP-5862 is identified to be the major active metabolite in plasma with a geometric mean exposure (AUC) that is about 2-3 times greater than the exposure of acalabrutinib. ACP-5862 is about 50% less potent than acalabrutinib in regards to the inhibition of BTK.


5.7 Biological Half-Life

After administering a single oral dose of 100 mg acalabrutinib, the median terminal elimination half-life of the drug was found to be 0.9 (with a range of 0.6 to 2.8) hours. The half-life of the active metabolite, ACP-5862, is about 6.9 hours.


5.8 Mechanism of Action

Mantle Cell Lymphoma (MCL) is a rare yet aggressive type of B-cell non-Hodgkin lymphoma (NHL) with poor prognosis. Subsequently, relapse is common in MCL patients and ultimately represents disease progression. Lymphoma occurs when immune system lymphocytes grow and multiply uncontrollably. Such cancerous lymphocytes may travel to many parts of the body, including the lymph nodes, spleen, bone marrow, blood, and other organs where they can multiply and form a mass(es) called a tumor. One of the main kinds of lymphocytes that can develop into cancerous lymphomas are the body's own B-lymphocytes (B-cells). Bruton Tyrosine Kinase (BTK) is a signalling molecule of the B-cell antigen receptor and cytokine receptor pathways. Such BTK signaling causes the activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. Acalabrutinib is a small molecule inhibitor of BTK. Both acalabrutinib and its active metabolite, ACP-5862, act to form a covalent bond with a cysteine residue (Cys481) in the BTK active site, leading to inhibition of BTK enzymatic activity. As a result, acalabrutinib inhibits BTK-mediated activation of downstream signaling proteins CD86 and CD69, which ultimately inhibits malignant B-cell proliferation and survival Whereas ibrutinib is typically recognized as the first-in-class BTK inhibitor, acalabrutinib is considered a second generation BTK inhibitor primarily because it demonstrates highter selectivity and inhibition of the targeted activity of BTK while having a much greater IC50 or otherwise virtually no inhibition on the kinase activities of ITK, EGFR, ERBB2, ERBB4, JAK3, BLK, FGR, FYN, HCK, LCK, LYN, SRC, and YES1. In effect, acalabrutinib was rationally designed to be more potent and selective than ibrutinib, all the while demonstrating fewer adverse effects - in theory - because of the drug's minimized off target effects.


KDMF

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Acalabrutinib

Registrant Name : AstraZeneca Korea Ltd.

Registration Date : 2021-02-05

Registration Number : Su248-15-ND

Manufacturer Name : Dottikon Exclusive Synthesis...

Manufacturer Address : Hembrunnstrasse 17, 5605 Dottikon, Switzerland

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Acalabrutinib maleate hydrate

Registrant Name : AstraZeneca Korea Ltd.

Registration Date : 2023-02-25

Registration Number : Su248-19-ND

Manufacturer Name : Dottikon Exclusive Synthesis...

Manufacturer Address : Hembrunnstrasse 17, 5605 Dottikon, Switzerland

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Acalabrutinib

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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About the Company : Egis, part of the Servier Group, manufactures products at three EMA-, FDA-, ANVISA-, PMDA-, and KFDA-certified sites in Hungary. It sells branded products in 18 countries and reach...

Egis, part of the Servier Group, manufactures products at three EMA-, FDA-, ANVISA-, PMDA-, and KFDA-certified sites in Hungary. It sells branded products in 18 countries and reaches 100 countries with its APIs and finished products. Egis focuses on cardiovascular and central nervous system diseases, with offerings in diabetology, dermatology, and wound care. Its R&D emphasizes high-quality, value-added branded generics, and since 2023, Egis also provides CDMO and CMO services. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Virtual BoothZhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

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About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...

Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming to global API standards, along with professional R&D and marketing teams, Hengkang’s operations span major pharmaceutical markets such as China, Europe, the CIS region, Japan, and South Korea. Hengkang has established long-term and stable relationships with nearly 70 countries overseas and hundreds of domestic enterprises. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Acalabrutinib

About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Cipla

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Acalabrutinib

About the Company : Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission i...

Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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About the Company : Guangzhou AANpharm Technology is a science-driven producer of key starting materials, pharmaceutical intermediates and specialty chemicals for CDMOs, API manufacturers and biotech ...

Guangzhou AANpharm Technology is a science-driven producer of key starting materials, pharmaceutical intermediates and specialty chemicals for CDMOs, API manufacturers and biotech innovators in regulated and semi-regulated markets. With 25 years of experience, the organization delivers scalable, customized manufacturing under GMP and ISO-compliant systems, supported by integrated R&D and QA/QC labs, complex multi-step synthesis capabilities, flexible batch sizes and dedicated project teams serving clients across North America, Europe and Asia.
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About the Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, cat...

Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and chemical products, catering to both export and import markets. The company consists of two primary business departments: the Professional Sourcing/Product Team and the Quality Team. Backed by experienced partners, Longshine has evolved into a trustworthy supplier of high-quality products and received ISO9001:2008 certification in 2017.
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About the Company : Consistent growth and sustainability is a multidimensional aspiration for all at Macleods, we remained focused on providing quality and affordable medicines to billions of ailing p...

Consistent growth and sustainability is a multidimensional aspiration for all at Macleods, we remained focused on providing quality and affordable medicines to billions of ailing patients across geographies and bridging the gap of unmet needs of medical fraternity through continuous innovation. Our basic business philosophy, by its very nature, serves a social responsibility hence we have a far better reason than profits alone to drive our performance. Sustainability, is not a trend we blindly follow, it is intrinsic to how we have operated since the genesis of the organization in the year 1986.
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Natco Pharma

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Natco Pharma

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About the Company : NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 e...

NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, NATCO today has five manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development, etc.NATCO family currently consists of more than 2500 employees, we are consistently ranked among fastest growing pharmaceutical companies in India. NATCO is well recognized for its innovation in Pharmaceutical R&D.
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API Reference Price

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ACALABRUTINIB","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"UNDISCLOSED","customerCountry":"JORDAN","quantity":"22.03","actualQuantity":"22.032","unit":"KGS","unitRateFc":"21000","totalValueFC":"456689.6","currency":"USD","unitRateINR":1881498.5312273058,"date":"12-Feb-2026","totalValueINR":"41453175.64","totalValueInUsd":"456689.6","indian_port":"Ahmedabad Air","hs_no":"29334990","bill_no":"0","productDescription":"API","marketType":"","country":"JORDAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691173800,"product":"ACALABRUTINIB D4FOR R&D PURPOSE ONLY","address":"B 64\/1, THIRD STAGE, ,PEENYA INDUSTRIAL ESTATE, ,,","city":"Bangalore","supplier":"ARTIS BIOTECH CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"BIOORGANICS AND APPLIED MATERIALS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"50","unit":"MGS","unitRateFc":"32","totalValueFC":"1611.5","currency":"USD","unitRateINR":"2643.2","date":"05-Aug-2023","totalValueINR":"133492.48","totalValueInUsd":"1611.5","indian_port":"BANGALORE AIR","hs_no":"29389090","bill_no":"0","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B 64\/1, THIRD STAGE, ,PEENYA INDUSTRIAL ESTATE, ,,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691173800,"product":"ACALABRUTINIB METABOLITE 27FOR R&D PURPOSE ONLY","address":"B 64\/1, THIRD STAGE, ,PEENYA INDUSTRIAL ESTATE, ,,","city":"Bangalore","supplier":"ARTIS BIOTECH CO LTD","supplierCountry":"CHINA","foreign_port":"NA","customer":"BIOORGANICS AND APPLIED MATERIALS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"100","unit":"MGS","unitRateFc":"20","totalValueFC":"2014.4","currency":"USD","unitRateINR":"1652","date":"05-Aug-2023","totalValueINR":"166865.6","totalValueInUsd":"2014.4","indian_port":"BANGALORE AIR","hs_no":"29389090","bill_no":"0","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B 64\/1, THIRD STAGE, ,PEENYA INDUSTRIAL ESTATE, ,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"ACALABRUTINIB","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"SICHUAN TAIENKANG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"JODAS EXPOIM PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"8800","totalValueFC":"8896.7","currency":"USD","unitRateINR":"747560","date":"25-Oct-2024","totalValueINR":"747560","totalValueInUsd":"8896.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6321991","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHENGDU","supplierAddress":"NO.22 JIANKANG ROAD ECONOMIC DEVELO PMENT ZONE YUECHI COUNTY 638300 SDNF China","customerAddress":"101, SITARAM MANSION,"}]
08-Aug-2022
12-Feb-2026
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ABOUT THIS PAGE

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 KDMF

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

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

After submitting a Acalabrutinib 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 Acalabrutinib API can apply through the Korea Drug Master File (KDMF).

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

Acalabrutinib WC

A Acalabrutinib written confirmation (Acalabrutinib WC) is an official document issued by a regulatory agency to a Acalabrutinib manufacturer, verifying that the manufacturing facility of a Acalabrutinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acalabrutinib APIs or Acalabrutinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Acalabrutinib WC (written confirmation) as part of the regulatory process.

click here to find a list of Acalabrutinib suppliers with Written Confirmation (WC) on PharmaCompass.

Acalabrutinib NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Acalabrutinib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Acalabrutinib API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Acalabrutinib as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Acalabrutinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acalabrutinib NDC to their finished compounded human drug products, they may choose to do so.

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

Acalabrutinib GMP

Acalabrutinib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Acalabrutinib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Acalabrutinib GMP manufacturer or Acalabrutinib GMP API supplier for your needs.

Acalabrutinib CoA

A Acalabrutinib CoA (Certificate of Analysis) is a formal document that attests to Acalabrutinib's compliance with Acalabrutinib specifications and serves as a tool for batch-level quality control.

Acalabrutinib CoA mostly includes findings from lab analyses of a specific batch. For each Acalabrutinib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Acalabrutinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Acalabrutinib EP), Acalabrutinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acalabrutinib USP).

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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