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Synopsis

Synopsis

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Chemistry

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Also known as: Abl-001, 1492952-76-7, Abl001, Asciminib free base, Abl001-nx, Nvp-abl001
Molecular Formula
C20H18ClF2N5O3
Molecular Weight
449.8  g/mol
InChI Key
VOVZXURTCKPRDQ-CQSZACIVSA-N
FDA UNII
L1F3R18W77

Asciminib
Asciminib is an orally bioavailable, allosteric Bcr-Abl1 tyrosine kinase inhibitor, with antineoplastic activity. Upon administration, asciminib targets and binds to the myristoyl pocket of the Bcr-Abl1 fusion protein at a location that is distinct from the ATP-binding domain, thereby inhibiting the activity of both wild-type Bcr-Abl and certain mutation forms, including the T315I mutation. This binding results in the inhibition of Bcr-Abl1-mediated proliferation and enhanced apoptosis of Philadelphia chromosome-positive (Ph+) hematological malignancies. The Bcr-Abl1 fusion protein tyrosine kinase is an abnormal enzyme produced by leukemia cells that contain the Philadelphia chromosome.
1 2D Structure

Asciminib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[4-[chloro(difluoro)methoxy]phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide
2.1.2 InChI
InChI=1S/C20H18ClF2N5O3/c21-20(22,23)31-15-3-1-13(2-4-15)26-19(30)12-9-16(17-5-7-25-27-17)18(24-10-12)28-8-6-14(29)11-28/h1-5,7,9-10,14,29H,6,8,11H2,(H,25,27)(H,26,30)/t14-/m1/s1
2.1.3 InChI Key
VOVZXURTCKPRDQ-CQSZACIVSA-N
2.1.4 Canonical SMILES
C1CN(CC1O)C2=C(C=C(C=N2)C(=O)NC3=CC=C(C=C3)OC(F)(F)Cl)C4=CC=NN4
2.1.5 Isomeric SMILES
C1CN(C[C@@H]1O)C2=C(C=C(C=N2)C(=O)NC3=CC=C(C=C3)OC(F)(F)Cl)C4=CC=NN4
2.2 Other Identifiers
2.2.1 UNII
L1F3R18W77
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Abl001

2. Asciminib Hydrochloride

2.3.2 Depositor-Supplied Synonyms

1. Abl-001

2. 1492952-76-7

3. Abl001

4. Asciminib Free Base

5. Abl001-nx

6. Nvp-abl001

7. Asciminib [usan]

8. Scemblix

9. Example 9

10. L1f3r18w77

11. 1492952-76-7 (free Base)

12. (r)-n-(4-(chlorodifluoromethoxy)phenyl)-6-(3-hydroxypyrrolidin-1-yl)-5-(1h-pyrazol-5-yl)nicotinamide

13. 3-pyridinecarboxamide, N-(4-(chlorodifluoromethoxy)phenyl)-6-((3r)-3-hydroxy-1-pyrrolidinyl)-5-(1h-pyrazol-3-yl)-

14. N-[4-[chloro(difluoro)methoxy]phenyl]-6-[(3r)-3-hydroxypyrrolidin-1-yl]-5-(1h-pyrazol-5-yl)pyridine-3-carboxamide

15. 3-pyridinecarboxamide, N-[4-(chlorodifluoromethoxy)phenyl]-6-[(3r)-3-hydroxy-1-pyrrolidinyl]-5-(1h-pyrazol-3-yl)-

16. Asciminib [inn]

17. Asciminib (abl001)

18. Asciminib (usan/inn)

19. Asciminib [who-dd]

20. Unii-l1f3r18w77

21. Gtpl8962

22. Chembl4208229

23. Schembl15388306

24. Tqp0925

25. Ex-a3030

26. Bdbm50459091

27. Nsc789925

28. S8555

29. Zinc150275965

30. At30330

31. Ccg-269232

32. Compound 1 [pmid: 30137981]

33. Cs-7655

34. Db12597

35. Nsc-789925

36. (r)-n- (4-(chlorodifluoromethoxy)phenyl)- 6-(3- Hydroxypyrrolidin-1- Yl)-5- (1h-pyrazol- 5-yl)nicotinamide

37. Ba166957

38. Bs-15538

39. Hy-104010

40. D11403

41. A910986

42. Q27074535

43. (r)-n-(4-(chloro Difluoromethoxy)phenyl)-6-(3-hydroxypyrrolidin-1-yl)-5-(1h-pyrazol-5-yl)nicotinamide

44. (r)-n-(4-(chlorodifluoromethoxy)phenyl)-6-(3-hydroxypyrrolidin-1-yl)-5-(1h-pyrazol-3-yl)nicotinamide

45. Ay7

46. N-(4-(chlorodifluoromethoxy)phenyl)-6-((3r)-3- Hydroxypyrrolidin-1-yl)-5-(1h-pyrazol-3-yl)pyridine- 3-carboxamide

2.4 Create Date
2013-12-02
3 Chemical and Physical Properties
Molecular Weight 449.8 g/mol
Molecular Formula C20H18ClF2N5O3
XLogP33
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count8
Rotatable Bond Count6
Exact Mass449.1066235 g/mol
Monoisotopic Mass449.1066235 g/mol
Topological Polar Surface Area103 Ų
Heavy Atom Count31
Formal Charge0
Complexity626
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 Indication

Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with 2 tyrosine kinase inhibitors. It is also indicated in the treatment of Ph+ CML in adult patients with the T315I mutation.


Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP) previously treated with two or more tyrosine kinase inhibitors (see section 5. 1).


5 Pharmacology and Biochemistry
5.1 Pharmacology

Asciminib exerts its therapeutic activity by inhibiting an oncogenic protein responsible for the proliferation of CML. It may be administered orally once or twice a day depending on the condition being treated. By increasing the total daily dose 5-fold as compared to standard therapy (80mg daily vs. 400mg daily), it can be used to treat Ph+ CML with the T315I mutation, a typically treatment-resistant variant of the disease. As with many other chemotherapeutic agents, asciminib treatment can result in various forms of myelosuppression, including thrombocytopenia and neutropenia. Patients should receive frequent laboratory monitoring throughout therapy and dose adjustments may be required based on the severity of observed effects. Patients may also experience pancreatic and/or cardiovascular toxicity, both of which require frequent monitoring and may require dose adjustments as per prescribing information.


5.2 ATC Code

L01EA06


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EA - Bcr-abl tyrosine kinase inhibitors

L01EA06 - Asciminib


5.3 Absorption, Distribution and Excretion

Absorption

The median Tmax of asciminib following oral administration is 2.5 hours. At a dose of 80mg once daily, the steady-state Cmax and AUCtau were 1781 ng/mL and 15112 ng.h/mL, respectively. At a dose of 40mg twice daily, the steady-state Cmax and AUCtau were 793 ng/mL and 5262 ng.h/mL, respectively. At a dose of 200mg twice daily (for treatment of T315I mutants), the steady-state Cmax and AUCtau were 5642 ng/mL and 37547 ng.h/mL, respectively. As compared to the fasted state, the co-administration of asciminib with a high-fat meal decreased the AUC and Cmax by 62% and 68%, respectively, and its co-administration with a low-fat meal decreased the AUC and Cmax by 30% and 35%, respectively.


Route of Elimination

Asciminib is eliminated via biliary secretion facilitated by breast cancer-resistant protein (BCRP) transporters. Following oral administration, approximately 80% and 11% of an asciminib dose was recovered in the feces and urine, respectively. Unchanged parent drug accounted for 57% of drug material recovered in the feces and 2.5% in the urine.


Volume of Distribution

At steady-state, the apparent volume of distribution of asciminib is 151 L.


Clearance

The total apparent clearance of asciminib is 6.7 L/h at a total daily dose of 80mg and 4.1 L/h at a dose of 200mg twice daily.


5.4 Metabolism/Metabolites

Asciminib is negligibly metabolized, with unchanged parent drug comprising the main drug component in plasma (~93%) and following excretion (~57% in feces). The main circulating metabolites are M30.5, M44, and M29.5, accounting for approximately 5%, 2%, and 0.4% of the total administered dose, respectively. The oxidative metabolism of asciminib is mediated by CYP3A4, and the glucuronidation of asciminib is mediated by UGT2B7 and UGT2B17.


5.5 Biological Half-Life

The terminal elimination half-life asciminib is 5.5 hours when administered at 40mg twice daily and 9.0 hours when administered at 200mg twice daily.


5.6 Mechanism of Action

In most patients with chronic myeloid leukemia (CML), progression of the disease is driven primarily by a translocation of the Philadelphia chromosome that creates an oncogenic fusion gene, _BCR-ABL1_, between the _BCR_ and _ABL1_ genes. This fusion gene produces a resultant fusion protein, BCR-ABL1, which exhibits elevated tyrosine kinase and transforming activities that contribute to CML proliferation. Asciminib is an allosteric inhibitor of the BCR-ABL1 tyrosine kinase. It binds to the myristoyl pocket of the ABL1 portion of the fusion protein and locks it into an inactive conformation, preventing its oncogenic activity.


API SUPPLIERS

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Biophore India Pharmaceuticals Pvt...

India

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TAPI Technology & API Services

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Fareva

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Biophore India Pharmaceuticals Pvt...

India

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Hetero Drugs

India

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Hetero Drugs

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MSN Laboratories

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MSN Laboratories

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Novartis Pharmaceuticals Corporati...

Switzerland

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Listed Suppliers

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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Asciminib

About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Asciminib

About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...

Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios with over 350 products, alongside tailored CDMO services. Leveraging deep expertise and diverse technologies, we deliver flexible, high-quality solutions to meet our partners’ needs. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
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Fareva

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asciminib hydrochloride

About the Company : Founded in 1990 in France, Fareva is a global subcontractor providing R&D, production, and packaging services across pharmaceutical, cosmetics, and industrial sectors. Operating in...

Founded in 1990 in France, Fareva is a global subcontractor providing R&D, production, and packaging services across pharmaceutical, cosmetics, and industrial sectors. Operating in 13 countries with 41 sites and 13,000+ employees, Fareva manufactures and packages products including sterile injectables, biological drugs, conventional formulations, medical devices, and food supplements. The company also produces APIs at three sites, covering highly potent, sterile, cytotoxic, hormonal, and steroid APIs. 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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Drugs in Development

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  • Development Update

Details:

Asciminib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of leukemia, myeloid.


Lead Product(s): Asciminib,Dasatinib

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 20, 2026

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University Health Network, Toronto

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University Health Network, Toronto

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Details : Asciminib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of leukemia, myeloid.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 20, 2026

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  • Development Update

Details:

Asciminib is a Miscellaneous drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.


Lead Product(s): Asciminib,Imatinib Mesylate,Dasatinib,Nilotinib

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 25, 2026

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University of Hong Kong

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University of Hong Kong

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Details : Asciminib is a Miscellaneous drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 25, 2026

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Details:

Asciminib is a small molecule drug, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of leukemia, lymphoid.


Lead Product(s): Asciminib,Dexamethasone,Vincristine Sulfate,Blinatumomab,Methotrexate,Cytarabine,Hydrocortisone,Prednisolone

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 04, 2026

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03

PEGS Boston Summit
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PEGS Boston Summit
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Details : Asciminib is a small molecule drug, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of leukemia, lymphoid.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 04, 2026

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Details:

Asciminib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of leukemia, myelogenous, chronic, bcr-abl positive.


Lead Product(s): Asciminib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 21, 2026

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04

PEGS Boston Summit
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PEGS Boston Summit
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Details : Asciminib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of leukemia, myelogenous, chronic, bcr-abl positive.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 21, 2026

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Details:

Asciminib is a small molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.


Lead Product(s): Asciminib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 26, 2025

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05

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Asciminib is a small molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

November 26, 2025

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  • Development Update

Details:

Asciminib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Breast Neoplasms.


Lead Product(s): Asciminib,Trastuzumab

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 22, 2025

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Duke University

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Duke University

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Details : Asciminib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Breast Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 22, 2025

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Details:

Scemblix (asciminib) is a tyrosine kinase inhibitor small molecule drug candidate which is indicated for newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia.


Lead Product(s): Asciminib,Imatinib Mesylate

Therapeutic Area: Oncology Brand Name: Scemblix

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 29, 2024

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07

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Scemblix (asciminib) is a tyrosine kinase inhibitor small molecule drug candidate which is indicated for newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia.

Product Name : Scemblix

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 29, 2024

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  • Development Update

Details:

Asciminib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Neoplasms.


Lead Product(s): Asciminib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 08, 2024

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08

MD Anderson Cancer Center

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MD Anderson Cancer Center

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Details : Asciminib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Neoplasms.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 08, 2024

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Details:

CTX-009 is a bispecific DLL4/VEGF-A antibody, it is being evaluated in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract tumors.


Lead Product(s): Asciminib,Paclitaxel

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 06, 2024

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09

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : CTX-009 is a bispecific DLL4/VEGF-A antibody, it is being evaluated in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract tumors.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 06, 2024

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Details:

Asciminib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Leukemia, Myelogenous, Chronic, BCR-ABL Positive.


Lead Product(s): Asciminib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 23, 2024

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10

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Asciminib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 23, 2024

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DATA COMPILATION #PharmaFlow

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DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 

Impressions: 4504

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

#PharmaFlow by PHARMACOMPASS
13 Nov 2025

STOCK RECAP #PipelineProspector

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Pipeline Prospector Oct 2024: Lundbeck acquires Longboard for US$ 2.6 bn; molecular glue degrader tech witnesses dealmaking
In October, several pharma companies posted their third quarter (Q3) results. Drugmakers like Pfizer, BMS, Roche, Novartis, Sanofi, Merck and Incyte reported higher-than-expected Q3 earnings, beating analyst expectations. Despite these healthy results, pharma indices continued on their downward journey that had begun in September. The Nasdaq Biotechnology Index (NBI) dropped 2.6 percent from 4,771.85 to 4,650.07. The SPDR S&P Biotech ETF (XBI) fell 1.6 percent from 98.61 to 97.03, and the S&P Biotechnology Select Industry Index (SPSIBI) decreased 1.9 percent from 7,707.4 to 7,561.29.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) Lundbeck buys Longboard, AbbVie picks up Aliada, Merck acquires Modifi in US$ 1 bn+ deals In mergers and acquisitions, Denmark’s Lundbeck agreed to buy California-based Longboard Pharmaceuticals for US$ 2.6 billion. The acquisition centers around bexicaserin, a promising phase 3 candidate for rare epilepsies including Dravet syndrome and Lennox-Gastaut syndrome, with Lundbeck projecting potential peak sales of US$ 1.5 billion to US$ 2 billion for this asset.  AbbVie acquired Boston-based Aliada Therapeutics for US$ 1.4 billion after reportedly outbidding at least three other drugmakers. The acquisition brings innovative blood-brain barrier technology to AbbVie’s portfolio, along with ALIA-1758, a phase 1 compound showing potential as a best-in-class therapy for Alzheimer’s disease. AbbVie also partnered with EvolveImmune Therapeutics in a potential US$ 1.4 billion deal (plus US$ 65 million upfront) to develop next-generation cancer biotherapeutics. The collaboration will leverage EvolveImmune’s innovative T-cell engager platform to create multispecific biologics targeting various oncology indications. Merck bolstered its oncology pipeline through the acquisition of Modifi Biosciences in a deal valued up to US$ 1.3 billion. The acquisition targets novel DNA modification therapeutics for challenging brain tumors, particularly glioblastomas. Merck  also entered into a potential US$ 1.9 billion deal with Mestag Therapeutics to explore fibroblast therapies for inflammatory diseases, leveraging Mestag’s innovative platform.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) Pfizer, Novartis, Biogen sign molecular glue degrader deals; Astra in US$ 2 bn pact with CSPC There were at least three deals signed in October in the molecular glue degrader technology space. These degraders represent a novel therapeutic approach by facilitating the degradation of disease-causing proteins that are otherwise difficult to target with conventional drugs. First, Pfizer partnered Triana Biomedicines in a deal potentially exceeding US$ 1.5 billion, focusing on cancer applications. Second, Novartis committed US$ 150 million upfront to Monte Rosa Therapeutics in a deal worth up to US$ 2.25 billion. And Biogen tied up with Neomorph, pledging up to US$ 1.45 billion for neurological and immunological applications. Among other deals, AstraZeneca entered into a US$ 2 billion licensing agreement with CSPC Pharmaceutical Group for a novel lipid-lowering therapy, while Recordati acquired global rights to Sanofi’s Enjaymo for US$ 825 million upfront, with additional milestone payments of up to US$ 250 million. The Recordati-Sanofi deal focuses on cold agglutinin disease (CAD), a rare autoimmune disorder, and includes rights to sutimlimab, the first and only targeted therapy for CAD patients. Roche demonstrated its commitment to gene therapy advancement by expanding its collaboration with Dyno Therapeutics, committing over US$ 1 billion for adeno-associated virus (AAV) vector development, with an upfront payment of US$ 50 million. This expanded partnership builds on their initial 2020 collaboration and aims to accelerate the development of innovative gene therapies for neurological diseases.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel) AbbVie wins FDA nod for subcutaneous Parkinson’s drug; Roche med okayed for breast cancer October marked significant advances in the treatment of several major diseases. FDA approved AbbVie’s Vyalev for advanced Parkinson’s disease. This innovative therapy, utilizing foscarbidopa and foslevodopa prodrugs, delivers round-the-clock symptom control through subcutaneous infusion. The treatment represents a major advancement in managing motor fluctuations in late-stage patients, with market analysts projecting peak sales exceeding US$ 2 billion. In the oncology space, a historic milestone was reached with FDA’s approval of Vyloy, the world’s first therapy targeting CLDN18.2 proteins in gastric cancer. Developed by Astellas, the drug was approved for use in combination with chemotherapy for treating advanced gastric or gastroesophageal junction adenocarcinoma in adults with HER2-negative, CLDN18.2-positive tumors. This approval validates Astellas’ strategic US$ 1.4 billion acquisition of Ganymed Pharmaceuticals in 2016. Roche strengthened its position in breast cancer treatment with the approval of Itovebi, an oral PI3K inhibitor for first-line treatment of advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation. This approval positions Itovebi as a strong competitor to existing treatments like Novartis' Piqray and AstraZeneca's Truqap, with Roche projecting annual peak sales of US$ 2.3 billion. Novartis expanded the reach of its leukemia treatment Scemblix through an accelerated approval for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. This expansion significantly increases the eligible patient population by approximately four times, building on its existing approval as a third-line treatment. Pfizer expanded its presence in the respiratory syncytial virus (RSV) market as FDA broadened the approval of Abrysvo to include at risk adults aged 18 to 50 years, making it the first and only RSV vaccine authorized for this population. In hematology, Pfizer secured approval for Hympavzi marking its second hemophilia approval in six months. This approval follows the earlier authorization of Pfizer’s one-time gene therapy Beqvez for hemophilia B in April. Iterum Therapeutics received FDA approval for its new oral antibiotic, Orlynvah, designed to treat uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative oral antibacterial treatment options. This marks the first US approval for an oral penem antibiotic.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)  Gilead withdraws Trodelvy, J&J discontinues late-stage study of its bladder cancer candidate In a notable development for bladder cancer treatment, Gilead Sciences announced the withdrawal of Trodelvy from the US market after the targeted therapy, which received accelerated FDA approval in 2021 for metastatic urothelial cancer, failed to demonstrate survival benefits in a crucial confirmatory study.  Johnson & Johnson decided to discontinue the late-stage study of TAR-200, their investigational bladder cancer therapy, after interim analysis showed no superior benefits compared to standard chemo-radiation therapy. In neurology, Marinus Pharmaceuticals faced disappointment when their phase 3 trial of oral ganaxolone (Ztalmy) failed to meet its primary endpoint in reducing seizures associated with tuberous sclerosis complex (a genetic disorder). Marinus’ stock fell nearly 100 percent in October.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)  Our view The last quarter was a good one for several drugmakers. Pfizer saw a surge in sales of its Covid drug Paxlovid to US$ 2.7 billion, encouraging it to up its guidance for Covid-related sales from US$ 8.5 billion to US$ 10.5 billion. For BMS, blockbusters like blood thinner Eliquis and cancer treatment Revlimid continued to bring in revenue. Merck’s growth was driven by the world’s top-selling drug, Keytruda, which saw revenue jump 17 percent compared to Q3 2023, beating analysts’ estimates. In a nutshell, the robust Q3 earnings of major pharma companies signals strong industry fundamentals, the volatility in pharma indices notwithstanding.  Access the Pipeline Prospector Dashboard for October 2024 Newsmakers (Free Excel)

Impressions: 4476

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-oct-2024-lundbeck-acquires-longboard-for-us-2-6-bn-molecular-glue-degrader-tech-witnesses-dealmaking

#PharmaFlow by PHARMACOMPASS
07 Nov 2024

NEWS #PharmaBuzz

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https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-oral-presentation-at-the-eha-2026-congress-featuring-additional-positive-phase-1-clinical-trial-data-for-elvn-001-in-cml-302769668.html

PR NEWSWIRE
12 May 2026

https://www.globenewswire.com/news-release/2026/03/03/3248265/0/en/Certara-Simcyp-Simulator-Results-Replace-Ten-Human-Trials-for-Chronic-Myeloid-Leukemia-CML-Therapy-asciminib.html

GLOBENEWSWIRE
03 Mar 2026

https://www.pharmacompass.com/pdf/news/fda-confirms-para-iv-patent-litigation-for-scemblix-46376.pdf

FDA
19 Jan 2026

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/more-patients-can-access-key-drugs-after-gst-tax-cuts/articleshow/123793821.cms

ECONOMICTIMES
10 Sep 2025

https://www.globenewswire.com/news-release/2025/05/14/3081256/0/en/Terns-Pharmaceuticals-Selected-for-Oral-Presentation-at-European-Hematology-Association-Congress-For-Preclinical-Data-on-Novel-Allosteric-BCR-ABL-Inhibitor-TERN-701.html

GLOBENEWSWIRE
14 May 2025

https://www.prnewswire.com/news-releases/live-from-ash-2024--1-5-year-follow-up-data-from-a-global-study-of-olverembatinib-reaffirms-potential-in-overcoming-resistanceintolerance-to-ponatinib-or-asciminib-302327550.html

PR NEWSWIRE
10 Dec 2024

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US Medicaid Prescriptions

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Brand Name : Scemblix

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Company : Novartis

Asciminib Hydrochloride

Drug Cost (USD) : 114,488,117

Year : 2023

Prescribers : 704

Prescriptions : 4397

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Brand Name : Scemblix

Switzerland
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Brand Name : Scemblix

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Company : Novartis

Asciminib Hydrochloride

Drug Cost (USD) : 52,486,018

Year : 2022

Prescribers : 415

Prescriptions : 2158

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Brand Name : Scemblix

Switzerland
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Brand Name : Scemblix

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Company : Novartis

Asciminib Hydrochloride

Drug Cost (USD) : 2,112,304

Year : 2021

Prescribers : 70

Prescriptions : 89

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ASCIMINIB HYDROCHLORIDE

Exclusivity Code : I-953

Exclusivity Expiration Date : 2027-10-29

Application Number : 215358

Product Number : 1

Exclusivity Details :

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Exclusivity Code : I-954

Exclusivity Expiration Date : 2027-10-29

Application Number : 215358

Product Number : 1

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Exclusivity Expiration Date : 2028-10-02

Application Number : 215358

Product Number : 1

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Exclusivity Expiration Date : 2026-10-29

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Product Number : 1

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ABOUT THIS PAGE

Looking for 1492952-76-7 / Asciminib API manufacturers, exporters & distributors?

Asciminib manufacturers, exporters & distributors 1

15

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

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

API | Excipient name

Asciminib

Synonyms

Abl-001, 1492952-76-7, Abl001, Asciminib free base, Abl001-nx, Nvp-abl001

Cas Number

1492952-76-7

Unique Ingredient Identifier (UNII)

L1F3R18W77

About Asciminib

Asciminib is an orally bioavailable, allosteric Bcr-Abl1 tyrosine kinase inhibitor, with antineoplastic activity. Upon administration, asciminib targets and binds to the myristoyl pocket of the Bcr-Abl1 fusion protein at a location that is distinct from the ATP-binding domain, thereby inhibiting the activity of both wild-type Bcr-Abl and certain mutation forms, including the T315I mutation. This binding results in the inhibition of Bcr-Abl1-mediated proliferation and enhanced apoptosis of Philadelphia chromosome-positive (Ph+) hematological malignancies. The Bcr-Abl1 fusion protein tyrosine kinase is an abnormal enzyme produced by leukemia cells that contain the Philadelphia chromosome.

Asciminib Manufacturers

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

Asciminib Suppliers

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

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

Asciminib USDMF

A Asciminib DMF (Drug Master File) is a document detailing the whole manufacturing process of Asciminib active pharmaceutical ingredient (API) in detail. Different forms of Asciminib DMFs exist exist since differing nations have different regulations, such as Asciminib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Asciminib DMF submitted to regulatory agencies in the US is known as a USDMF. Asciminib USDMF includes data on Asciminib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Asciminib USDMF is kept confidential to protect the manufacturer’s intellectual property.

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

Asciminib KDMF

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

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

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

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

Asciminib 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 Asciminib as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Asciminib 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 Asciminib 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 Asciminib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Asciminib NDC to their finished compounded human drug products, they may choose to do so.

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

Asciminib GMP

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

Asciminib CoA

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

Asciminib CoA mostly includes findings from lab analyses of a specific batch. For each Asciminib 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.

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