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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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VMF

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PATENTS & EXCLUSIVITIES

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Health Canada Patents

GLOBAL SALES INFORMATION

US Medicaid

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Chemistry

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Also known as: 1365267-27-1, X-376, X-396, 7dr7jmb8bh, Chembl2376648, 6-amino-5-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-n-[4-(4-methylpiperazine-1-carbonyl)phenyl]pyridazine-3-carboxamide
Molecular Formula
C25H25Cl2FN6O3
Molecular Weight
547.4  g/mol
InChI Key
ONPGOSVDVDPBCY-CQSZACIVSA-N
FDA UNII
7DR7JMB8BH

Ensartinib
X-396 has been used in trials studying the treatment of Advanced Solid Tumors and Non-small Cell Lung Cancer.
1 2D Structure

Ensartinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
6-amino-5-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-N-[4-(4-methylpiperazine-1-carbonyl)phenyl]pyridazine-3-carboxamide
2.1.2 InChI
InChI=1S/C25H25Cl2FN6O3/c1-14(21-17(26)7-8-18(28)22(21)27)37-20-13-19(31-32-23(20)29)24(35)30-16-5-3-15(4-6-16)25(36)34-11-9-33(2)10-12-34/h3-8,13-14H,9-12H2,1-2H3,(H2,29,32)(H,30,35)/t14-/m1/s1
2.1.3 InChI Key
ONPGOSVDVDPBCY-CQSZACIVSA-N
2.1.4 Canonical SMILES
CC(C1=C(C=CC(=C1Cl)F)Cl)OC2=CC(=NN=C2N)C(=O)NC3=CC=C(C=C3)C(=O)N4CCN(CC4)C
2.1.5 Isomeric SMILES
C[C@H](C1=C(C=CC(=C1Cl)F)Cl)OC2=CC(=NN=C2N)C(=O)NC3=CC=C(C=C3)C(=O)N4CCN(CC4)C
2.2 Other Identifiers
2.2.1 UNII
7DR7JMB8BH
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 6-amino-5-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-n-(4-(4-methylpiperazine-1-carbonyl)phenyl)pyridazine-3-carboxamide

2. Ensartinib

3. X-396

2.3.2 Depositor-Supplied Synonyms

1. 1365267-27-1

2. X-376

3. X-396

4. 7dr7jmb8bh

5. Chembl2376648

6. 6-amino-5-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-n-[4-(4-methylpiperazine-1-carbonyl)phenyl]pyridazine-3-carboxamide

7. 3-pyridazinecarboxamide, 6-amino-5-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-n-(4-((4-methyl-1-piperazinyl)carbonyl)phenyl)-

8. Unii-7dr7jmb8bh

9. Gtpl8959

10. Schembl15131466

11. Bcp07190

12. Ex-a2227

13. Bdbm50432894

14. Nsc800968

15. S6505

16. Zinc96258164

17. Cs-6077

18. Db13104

19. Nsc-800968

20. Example 18 [wo2012048259]

21. Ac-35751

22. Hy-16590

23. X376

24. X 396

25. X-376; X-396

26. Q27077191

2.4 Create Date
2012-05-14
3 Chemical and Physical Properties
Molecular Weight 547.4 g/mol
Molecular Formula C25H25Cl2FN6O3
XLogP33.2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count6
Exact Mass546.1349222 g/mol
Monoisotopic Mass546.1349222 g/mol
Topological Polar Surface Area114 Ų
Heavy Atom Count37
Formal Charge0
Complexity784
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Antineoplastic Agents

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


Protein Kinase Inhibitors

Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)


Drugs in Development

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Details:

As part of the agreement, Ensartinib will target ALK tyrosine kinase receptor in Non-Small-Cell Lung Carcinoma.


Lead Product(s): Ensartinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Ensacove

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Eversana

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement April 27, 2026

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01

Xcovery

U.S.A
arrow
RDD
Not Confirmed

Xcovery

U.S.A
arrow
RDD
Not Confirmed

Details : As part of the agreement, Ensartinib will target ALK tyrosine kinase receptor in Non-Small-Cell Lung Carcinoma.

Product Name : Ensacove

Product Type : Miscellaneous

Upfront Cash : Undisclosed

April 27, 2026

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Details:

MCLA-129 (Pamvatamig) is a antibody drug, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of neoplasms.


Lead Product(s): Pamvatamig,Ensartinib

Therapeutic Area: Oncology Brand Name: MCLA-129

Study Phase: Phase I/ Phase IIProduct Type: Antibody, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 04, 2026

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RDD
Not Confirmed
RDD
Not Confirmed

Details : MCLA-129 (Pamvatamig) is a antibody drug, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of neoplasms.

Product Name : MCLA-129

Product Type : Antibody, Unconjugated

Upfront Cash : Inapplicable

March 04, 2026

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  • Development Update

Details:

Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.


Lead Product(s): Ensartinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Betta Pharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 17, 2025

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Peking University Cancer Hospital & Institute

Country
arrow
RDD
Not Confirmed

Peking University Cancer Hospital & Institute

Country
arrow
RDD
Not Confirmed

Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 17, 2025

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Details:

Ensacove (ensartinib) is an ALK inhibitor, small molecule drug candidate, which is indicated for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).


Lead Product(s): Ensartinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Ensacove

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 18, 2024

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Xcovery

U.S.A
arrow
RDD
Not Confirmed

Xcovery

U.S.A
arrow
RDD
Not Confirmed

Details : Ensacove (ensartinib) is an ALK inhibitor, small molecule drug candidate, which is indicated for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

Product Name : Ensacove

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 18, 2024

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Details:

Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Ensartinib,Rifampicin,Itraconazole

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 09, 2024

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05

RDD
Not Confirmed
RDD
Not Confirmed

Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 09, 2024

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Details:

X-396 (ensartinib), an Anaplastic Lymphoma Kinase (ALK) inhibitor, its NDA filling has been accepted by USFDA, for adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).


Lead Product(s): Ensartinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 13, 2024

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06

Xcovery

U.S.A
arrow
RDD
Not Confirmed

Xcovery

U.S.A
arrow
RDD
Not Confirmed

Details : X-396 (ensartinib), an Anaplastic Lymphoma Kinase (ALK) inhibitor, its NDA filling has been accepted by USFDA, for adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 13, 2024

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Details:

Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.


Lead Product(s): Ensartinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 22, 2022

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07

RDD
Not Confirmed
RDD
Not Confirmed

Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 22, 2022

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Details:

NMPA’s nod in China marked first ensartinib approval based on results of eXalt3 study, an Xcovery sponsored randomized global phase III study, designed to evaluate the efficacy and safety of ensartinib in the first-line treatment of ALK-positive NSCLC.


Lead Product(s): Ensartinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Betta Pharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 22, 2022

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08

Xcovery

U.S.A
arrow
RDD
Not Confirmed

Xcovery

U.S.A
arrow
RDD
Not Confirmed

Details : NMPA’s nod in China marked first ensartinib approval based on results of eXalt3 study, an Xcovery sponsored randomized global phase III study, designed to evaluate the efficacy and safety of ensartinib in the first-line treatment of ALK-positive NSCLC.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 22, 2022

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Details:

Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.


Lead Product(s): Ensartinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Fudan University

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 04, 2020

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09

RDD
Not Confirmed
RDD
Not Confirmed

Lead Product(s) : Ensartinib,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Fudan University

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 04, 2020

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Details:

Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.


Lead Product(s): Ensartinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 31, 2019

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10

Xcovery

U.S.A
arrow
RDD
Not Confirmed

Xcovery

U.S.A
arrow
RDD
Not Confirmed

Details : Ensartinib is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Carcinoma, Non-Small-Cell Lung.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 31, 2019

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FDA Orange Book

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01

XCOVERY

U.S.A
RDD
Not Confirmed
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XCOVERY

U.S.A
arrow
RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

Brand Name : ENSACOVE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 25MG BASE

Approval Date : 2024-12-18

Application Number : 218171

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

XCOVERY

U.S.A
RDD
Not Confirmed
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XCOVERY

U.S.A
arrow
RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

Brand Name : ENSACOVE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2024-12-18

Application Number : 218171

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

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01

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RDD
Not Confirmed

XCOVERY

U.S.A
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RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

US Patent Number : 9296724

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 218171

Patent Use Code : U-4099

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-06-18

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02

arrow
RDD
Not Confirmed

XCOVERY

U.S.A
arrow
RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

US Patent Number : 9126947

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 218171

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-11-29

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03

arrow
RDD
Not Confirmed

XCOVERY

U.S.A
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RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

US Patent Number : 8551995

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 218171

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-02-09

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04

arrow
RDD
Not Confirmed

XCOVERY

U.S.A
arrow
RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

US Patent Number : 8551995

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 218171

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-02-09

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05

arrow
RDD
Not Confirmed

XCOVERY

U.S.A
arrow
RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

US Patent Number : 9126947

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 218171

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-11-29

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06

arrow
RDD
Not Confirmed

XCOVERY

U.S.A
arrow
RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

US Patent Number : 10899744

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 218171

Patent Use Code : U-4099

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-06-01

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07

arrow
RDD
Not Confirmed

XCOVERY

U.S.A
arrow
RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

US Patent Number : 10899744

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 218171

Patent Use Code : U-4099

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-06-01

blank

08

arrow
RDD
Not Confirmed

XCOVERY

U.S.A
arrow
RDD
Not Confirmed

ENSARTINIB HYDROCHLORIDE

US Patent Number : 9296724

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 218171

Patent Use Code : U-4099

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-06-18

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ABOUT THIS PAGE

Looking for 1365267-27-1 / Ensartinib API manufacturers, exporters & distributors?

Ensartinib manufacturers, exporters & distributors 1

14

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

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

API | Excipient name

Ensartinib

Synonyms

1365267-27-1, X-376, X-396, 7dr7jmb8bh, Chembl2376648, 6-amino-5-[(1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-n-[4-(4-methylpiperazine-1-carbonyl)phenyl]pyridazine-3-carboxamide

Cas Number

1365267-27-1

Unique Ingredient Identifier (UNII)

7DR7JMB8BH

About Ensartinib

X-396 has been used in trials studying the treatment of Advanced Solid Tumors and Non-small Cell Lung Cancer.

Ensartinib Manufacturers

A Ensartinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ensartinib, including repackagers and relabelers. The FDA regulates Ensartinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ensartinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Ensartinib Suppliers

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

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

Ensartinib 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 Ensartinib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ensartinib GMP

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

Ensartinib CoA

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

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

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