Synopsis
Synopsis
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CEP/COS
0
JDMF
0
EU WC
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
Regulatory FDF Prices
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1. Abl001
2. Asciminib Hydrochloride
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
| Molecular Weight | 449.8 g/mol |
|---|---|
| Molecular Formula | C20H18ClF2N5O3 |
| XLogP3 | 3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 6 |
| Exact Mass | 449.1066235 g/mol |
| Monoisotopic Mass | 449.1066235 g/mol |
| Topological Polar Surface Area | 103 Ų |
| Heavy Atom Count | 31 |
| Formal Charge | 0 |
| Complexity | 626 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
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).
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.
L01EA06
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01E - Protein kinase inhibitors
L01EA - Bcr-abl tyrosine kinase inhibitors
L01EA06 - Asciminib
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.
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.
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.
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.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Product Not Available For Sales
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-06-20
Pay. Date : 2025-05-29
DMF Number : 41014
Submission : 2024-12-31
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Product Not Available For Sales
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-06-25
Pay. Date : 2025-05-29
DMF Number : 41393
Submission : 2025-02-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-09-17
Pay. Date : 2025-07-29
DMF Number : 42298
Submission : 2025-07-29
Status : Active
Type : II
NDC Package Code : 68554-0181
Start Marketing Date : 2021-10-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2025-09-18
Pay. Date : 2025-07-23
DMF Number : 42260
Submission : 2025-07-18
Status : Active
Type : II
NDC Package Code : 54893-0517
Start Marketing Date : 2025-07-18
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 44139-0104
Start Marketing Date : 2021-10-29
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Novartis Korea
Registration Date : 2024-11-20
Registration Number : Su196-31-ND
Manufacturer Name : Novartis Pharma Schweizerhalle AG
Manufacturer Address : Rothausstrasse, 4133, Pratteln, Switzerland

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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&...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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 ...
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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

Lead Product(s) : Asciminib,Dasatinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
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

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

Lead Product(s) : Asciminib,Imatinib Mesylate,Dasatinib,Nilotinib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
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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Lead Product(s) : Asciminib, Dexamethasone, Vincristine Sulfate, Blinatumomab, Methotrexate
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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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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

Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP
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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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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Lead Product(s) : Asciminib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL
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

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

Lead Product(s) : Asciminib,Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
Asciminib in HER2+ Breast Cancer Brain Metastases
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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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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Lead Product(s) : Asciminib,Imatinib Mesylate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Scemblix® Approved By FDA for CML with Superior Efficacy and Safety
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

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

Lead Product(s) : Asciminib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
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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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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Lead Product(s) : Asciminib,Paclitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Compass Completes Enrollment in COMPANION-002 Study of CTX-009 in Biliary Tract Cancer
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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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

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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12 May 2026
// PR NEWSWIRE
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

03 Mar 2026
// GLOBENEWSWIRE
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

19 Jan 2026
// FDA
https://www.pharmacompass.com/pdf/news/fda-confirms-para-iv-patent-litigation-for-scemblix-46376.pdf

10 Sep 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/more-patients-can-access-key-drugs-after-gst-tax-cuts/articleshow/123793821.cms

14 May 2025
// GLOBENEWSWIRE
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

10 Dec 2024
// PR NEWSWIRE
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
Global Sales Information
Company : Novartis
Asciminib Hydrochloride
Drug Cost (USD) : 114,488,117
Year : 2023
Prescribers : 704
Prescriptions : 4397

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Company : Novartis
Asciminib Hydrochloride
Drug Cost (USD) : 52,486,018
Year : 2022
Prescribers : 415
Prescriptions : 2158

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Product Web Link
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Website
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Company : Novartis
Asciminib Hydrochloride
Drug Cost (USD) : 2,112,304
Year : 2021
Prescribers : 70
Prescriptions : 89

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Website
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19 Dec 2024

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