Find Zongertinib manufacturers, exporters & distributors on PharmaCompass

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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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USDMF

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CEP/COS

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JDMF

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EU WC

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KDMF

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VMF

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Listed Suppliers

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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FINISHED DOSAGE FORMULATIONS

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Europe

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Canada

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Australia

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South Africa

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DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

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API REF. PRICE (USD/KG)

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GLOBAL SALES INFORMATION

US Medicaid

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Regulatory FDF Prices

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MARKET PLACE

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API

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FDF

DIGITAL CONTENT

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Data Compilation #PharmaFlow

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Chemistry

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Also known as: 2728667-27-2, N-(1-(8-((3-methyl-4-((1-methyl-1h-benzo[d]imidazol-5-yl)oxy)phenyl)amino)pyrimido[5,4-d]pyrimidin-2-yl)piperidin-4-yl)acrylamide, Bi1810631, Bi-1810631, N-[1-[4-[3-methyl-4-(1-methylbenzimidazol-5-yl)oxyanilino]pyrimido[5,4-d]pyrimidin-6-yl]piperidin-4-yl]prop-2-enamide, Zongertinib?
Molecular Formula
C29H29N9O2
Molecular Weight
535.6  g/mol
InChI Key
YSGNGFPNTLERCR-UHFFFAOYSA-N
FDA UNII
DRH7R67UVL

Zongertinib
Zongertinib is an orally bioavailable inhibitor of the receptor tyrosine kinase human epidermal growth factor receptor 2 (HER2; ErbB2; HER-2), with potential antineoplastic activity. Upon oral administration, zongertinib covalently binds to and inhibits the activity of both wild-type and HER2 mutants, including HER2 mutants with exon 20 insertion (ex20ins) mutations. This prevents HER2-mediated signaling and may lead to cell death in HER2-expressing tumor cells. HER2, a receptor tyrosine kinase overexpressed on a variety of tumor cell types, plays an important role in tumor cell proliferation and tumor vascularization.
1 2D Structure

Zongertinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[1-[4-[3-methyl-4-(1-methylbenzimidazol-5-yl)oxyanilino]pyrimido[5,4-d]pyrimidin-6-yl]piperidin-4-yl]prop-2-enamide
2.1.2 InChI
InChI=1S/C29H29N9O2/c1-4-26(39)34-19-9-11-38(12-10-19)29-30-15-23-27(36-29)28(32-16-31-23)35-20-5-8-25(18(2)13-20)40-21-6-7-24-22(14-21)33-17-37(24)3/h4-8,13-17,19H,1,9-12H2,2-3H3,(H,34,39)(H,31,32,35)
2.1.3 InChI Key
YSGNGFPNTLERCR-UHFFFAOYSA-N
2.2 Other Identifiers
2.2.1 UNII
DRH7R67UVL
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 2728667-27-2

2. N-(1-(8-((3-methyl-4-((1-methyl-1h-benzo[d]imidazol-5-yl)oxy)phenyl)amino)pyrimido[5,4-d]pyrimidin-2-yl)piperidin-4-yl)acrylamide

3. Bi1810631

4. Bi-1810631

5. N-[1-[4-[3-methyl-4-(1-methylbenzimidazol-5-yl)oxyanilino]pyrimido[5,4-d]pyrimidin-6-yl]piperidin-4-yl]prop-2-enamide

6. Zongertinib?

7. Zongertinib [inn]

8. Drh7r67uvl

9. Zongertinib [usan]

10. Zongertinib (jan/usan/inn)

11. Chembl5314498

12. Schembl23957509

13. Gtpl12387

14. Wlz3778

15. Glxc-27939

16. Ex-a8033

17. Nsc854531

18. Nsc-854531

19. Da-59312

20. Ts-09568

21. Example I-01 [wo2021213800a1]

22. Hy-148810

23. Cs-0641245

24. D12879

25. G65208

26. 2-propenamide, N-[1-[8-[[3-methyl-4-[(1-methyl-1h-benzimidazol-5-yl)oxy]phenyl]amino]pyrimido[5,4-d]pyrimidin-2-yl]-4-piperidinyl]-

27. N-[1-(8-{3-methyl-4-[(1-methyl-1h-1,3-benzimidazol-5- Yl)oxy]anilino}pyrimido[5,4-d]pyrimidin-2-yl)piperidin-4- Yl]prop-2-enamide

2.4 Create Date
2021-12-03
3 Chemical and Physical Properties
Molecular Weight 535.6 g/mol
Molecular Formula C29H29N9O2
XLogP34.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count9
Rotatable Bond Count7
Exact Mass g/mol
Monoisotopic Mass g/mol
Topological Polar Surface Area123
Heavy Atom Count40
Formal Charge0
Complexity870
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

API SUPPLIERS

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01

Boehringer Ingelheim GmbH

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Nutri Ingredients Summit
Not Confirmed
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Boehringer Ingelheim GmbH

Germany

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Nutri Ingredients Summit
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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02

Eurofins CDMO

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Nutri Ingredients Summit
Not Confirmed
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Eurofins CDMO

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Nutri Ingredients Summit
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT arrow-down
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03

Hovione

Portugal

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Nutri Ingredients Summit
Not Confirmed
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Hovione

Portugal

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Nutri Ingredients Summit
Not Confirmed
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NDC API

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01

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ZONGERTINIB

NDC Package Code : 12714-301

Start Marketing Date : 2025-09-02

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (5kg/5kg)

Marketing Category : BULK INGREDIENT

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02

Nutri Ingredients Summit
Not Confirmed
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ZONGERTINIB

NDC Package Code : 43076-031

Start Marketing Date : 2025-08-08

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : DRUG FOR FURTHER PROCESSING

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Nutri Ingredients Summit
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ZONGERTINIB

NDC Package Code : 50909-1914

Start Marketing Date : 2025-08-08

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (50kg/100kg)

Marketing Category : DRUG FOR FURTHER PROCESSING

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Drugs in Development

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Details:

The collaboration aims to advance Zongertinib for ERBB2 in HER2-positive breast cancer.


Lead Product(s): Zongertinib,Zanidatamab

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

Sponsor: Jazz Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration January 12, 2026

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Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : The collaboration aims to advance Zongertinib for ERBB2 in HER2-positive breast cancer.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Undisclosed

January 12, 2026

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Details:

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


Lead Product(s): Zongertinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 29, 2025

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02

Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : Zongertinib is a Small Molecule drug candidate 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

September 29, 2025

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Details:

Hernexeos (zongertinib) is a ERBB2 blocker indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer.


Lead Product(s): Zongertinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Hernexeos

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 01, 2025

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03

Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : Hernexeos (zongertinib) is a ERBB2 blocker indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer.

Product Name : Hernexeos

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 01, 2025

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Details:

Hernexeos (zongertinib) is a kinase inhibitor indicated for the treatment of adults with unresectable or metastatic non-squamous NSCLC whose tumors have ERBB2 tyrosine kinase mutations.


Lead Product(s): Zongertinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Hernexeos

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 08, 2025

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04

Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : Hernexeos (zongertinib) is a kinase inhibitor indicated for the treatment of adults with unresectable or metastatic non-squamous NSCLC whose tumors have ERBB2 tyrosine kinase mutations.

Product Name : Hernexeos

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 08, 2025

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Details:

BI 1810631 (zongertinib) is an investigational oral HER2 tyrosine kinase inhibitor (TKI) in development being investigated in patients with advanced NSCLC with activating HER2 mutations.


Lead Product(s): Zongertinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 19, 2025

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05

Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : BI 1810631 (zongertinib) is an investigational oral HER2 tyrosine kinase inhibitor (TKI) in development being investigated in patients with advanced NSCLC with activating HER2 mutations.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 19, 2025

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Details:

Zongertinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Liver Diseases.


Lead Product(s): Zongertinib,Inapplicable

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 18, 2024

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06

Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : Zongertinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Liver Diseases.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

November 18, 2024

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Details:

BI 1810631 (zongertinib) is an investigational oral HER2 tyrosine kinase inhibitor (TKI) in development being investigated in patients with advanced NSCLC with activating HER2 mutations.


Lead Product(s): Zongertinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 09, 2024

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07

Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : BI 1810631 (zongertinib) is an investigational oral HER2 tyrosine kinase inhibitor (TKI) in development being investigated in patients with advanced NSCLC with activating HER2 mutations.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 09, 2024

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Details:

Zongertinib 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): Zongertinib,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 03, 2024

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08

Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : Zongertinib 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

September 03, 2024

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Details:

Zongertinib 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): Zongertinib,Dabigatran Etexilate Mesylate,Rosuvastatin Calcium,Metformin,Furosemide

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 17, 2024

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09

Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : Zongertinib 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 17, 2024

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Details:

Zongertinib 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): Zongertinib,Midazolam,Omeprazole,Repaglinide

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 10, 2024

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10

Nutri Ingredients Summit
Not Confirmed
Nutri Ingredients Summit
Not Confirmed

Details : Zongertinib 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 10, 2024

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ABOUT THIS PAGE

Looking for 2728667-27-2 / Zongertinib API manufacturers, exporters & distributors?

Zongertinib manufacturers, exporters & distributors 1

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

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

PharmaCompass also assists you with knowing the Zongertinib API Price utilized in the formulation of products. Zongertinib API Price is not always fixed or binding as the Zongertinib Price is obtained through a variety of data sources. The Zongertinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Zongertinib

Synonyms

2728667-27-2, N-(1-(8-((3-methyl-4-((1-methyl-1h-benzo[d]imidazol-5-yl)oxy)phenyl)amino)pyrimido[5,4-d]pyrimidin-2-yl)piperidin-4-yl)acrylamide, Bi1810631, Bi-1810631, N-[1-[4-[3-methyl-4-(1-methylbenzimidazol-5-yl)oxyanilino]pyrimido[5,4-d]pyrimidin-6-yl]piperidin-4-yl]prop-2-enamide, Zongertinib?

Cas Number

2728667-27-2

Unique Ingredient Identifier (UNII)

DRH7R67UVL

About Zongertinib

Zongertinib is an orally bioavailable inhibitor of the receptor tyrosine kinase human epidermal growth factor receptor 2 (HER2; ErbB2; HER-2), with potential antineoplastic activity. Upon oral administration, zongertinib covalently binds to and inhibits the activity of both wild-type and HER2 mutants, including HER2 mutants with exon 20 insertion (ex20ins) mutations. This prevents HER2-mediated signaling and may lead to cell death in HER2-expressing tumor cells. HER2, a receptor tyrosine kinase overexpressed on a variety of tumor cell types, plays an important role in tumor cell proliferation and tumor vascularization.

2728667-27-2 Manufacturers

A 2728667-27-2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2728667-27-2, including repackagers and relabelers. The FDA regulates 2728667-27-2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2728667-27-2 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

2728667-27-2 Suppliers

A 2728667-27-2 supplier is an individual or a company that provides 2728667-27-2 active pharmaceutical ingredient (API) or 2728667-27-2 finished formulations upon request. The 2728667-27-2 suppliers may include 2728667-27-2 API manufacturers, exporters, distributors and traders.

click here to find a list of 2728667-27-2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

2728667-27-2 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 2728667-27-2 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 2728667-27-2 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 2728667-27-2 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 2728667-27-2 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 2728667-27-2 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 2728667-27-2 suppliers with NDC on PharmaCompass.

2728667-27-2 GMP

2728667-27-2 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 2728667-27-2 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right 2728667-27-2 GMP manufacturer or 2728667-27-2 GMP API supplier for your needs.

2728667-27-2 CoA

A 2728667-27-2 CoA (Certificate of Analysis) is a formal document that attests to 2728667-27-2's compliance with 2728667-27-2 specifications and serves as a tool for batch-level quality control.

2728667-27-2 CoA mostly includes findings from lab analyses of a specific batch. For each 2728667-27-2 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.

2728667-27-2 may be tested according to a variety of international standards, such as European Pharmacopoeia (2728667-27-2 EP), 2728667-27-2 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (2728667-27-2 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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