Find Acebrophylline manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

USDMF

0

CEP/COS

0

JDMF

0

NDC API

0

VMF

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FINISHED DOSAGE FORMULATIONS

0

FDA Orange Book

0

Canada

0

Australia

0

South Africa

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

US Patents

0

US Exclusivities

0

Health Canada Patents

GLOBAL SALES INFORMATION

US Medicaid

NA

Annual Reports

NA

MARKET PLACE

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

0

News #PharmaBuzz

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: Ambroxol acefyllinate, Ambromucil, Broncomnes, Surfolase, 96989-76-3, Ambroxol theophyllinacetate
Molecular Formula
C22H28Br2N6O5
Molecular Weight
616.3  g/mol
InChI Key
IPUHJDQWESJTGD-UHFFFAOYSA-N
FDA UNII
0HM1E174TN

Acebrophylline
1 2D Structure

Acebrophylline

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol;2-(1,3-dimethyl-2,6-dioxopurin-7-yl)acetic acid
2.1.2 InChI
InChI=1S/C13H18Br2N2O.C9H10N4O4/c14-9-5-8(13(16)12(15)6-9)7-17-10-1-3-11(18)4-2-10;1-11-7-6(8(16)12(2)9(11)17)13(4-10-7)3-5(14)15/h5-6,10-11,17-18H,1-4,7,16H2;4H,3H2,1-2H3,(H,14,15)
2.1.3 InChI Key
IPUHJDQWESJTGD-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN1C2=C(C(=O)N(C1=O)C)N(C=N2)CC(=O)O.C1CC(CCC1NCC2=C(C(=CC(=C2)Br)Br)N)O
2.2 Other Identifiers
2.2.1 UNII
0HM1E174TN
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Ambroxol-theophylline-7-acetate

2.3.2 Depositor-Supplied Synonyms

1. Ambroxol Acefyllinate

2. Ambromucil

3. Broncomnes

4. Surfolase

5. 96989-76-3

6. Ambroxol Theophyllinacetate

7. 179118-73-1

8. Ambroxol-theophylline-7-acetate

9. Ambroxol Theophyllinate

10. 0hm1e174tn

11. 4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol;2-(1,3-dimethyl-2,6-dioxopurin-7-yl)acetic Acid

12. Cyclohexanol, 4-(((2-amino-3,5-dibromophenyl)methyl)amino)-, Trans-, Mono(1,2,3,6-tetrahydro-1,3-dimethyl-2,6-dioxo-7h-purine-7-acetate) (salt)

13. Unii-0hm1e174tn

14. Schembl1650322

15. Chembl4297663

16. Dtxsid60914235

17. Glxc-26022

18. Bcp28655

19. Ambroxol Acefyllinate [mart.]

20. Akos015899892

21. Ambroxol Acefyllinate [who-dd]

22. Db13141

23. Ambroxol Theophyllinate [who-dd]

24. Ambromucil Pound>>ambroxol-theophylline-7-acetate

25. Q19607226

26. (1,3-dimethyl-2,6-dioxo-1,2,3,6-tetrahydro-7h-purin-7-yl)acetic Acid--4-{[(2-amino-3,5-dibromophenyl)methyl]amino}cyclohexan-1-ol (1/1)

27. 7h-purine-7-acetic Acid, 1,2,3,6-tetrahydro-1,3-dimethyl-2,6-dioxo-, Compd. With Trans-4-(((2-amino-3,5-dibromophenyl)methyl)amino)cyclohexanol (1:1)

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 616.3 g/mol
Molecular Formula C22H28Br2N6O5
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count8
Rotatable Bond Count5
Exact Mass616.04674 g/mol
Monoisotopic Mass614.04879 g/mol
Topological Polar Surface Area154 Ų
Heavy Atom Count35
Formal Charge0
Complexity645
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

Drugs in Development

read-more
read-more

Details:

Acebrophylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pulmonary Disease, Chronic Obstructive.


Lead Product(s): Acebrophylline,Acetylcysteine

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 30, 2024

blank

01

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Acebrophylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pulmonary Disease, Chronic Obstructive.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 30, 2024

blank

Details:

Acebrophylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Bronchitis.


Lead Product(s): Acebrophylline,Acetylcysteine

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Kwang-Ha Yoo

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 14, 2023

blank

02

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

Details : Acebrophylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Bronchitis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 14, 2023

blank

Details:

Acebrophylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Bronchitis.


Lead Product(s): Acebrophylline,Inapplicable

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 08, 2016

blank

03

Hyundai Pharm

South Korea
arrow
PEGS Boston Summit
Not Confirmed

Hyundai Pharm

South Korea
arrow
PEGS Boston Summit
Not Confirmed

Details : Acebrophylline is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Bronchitis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 08, 2016

blank

Details:

Surfolase is a Enzyme drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Acebrophylline,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Enzyme

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 24, 2015

blank

04

Hyundai Pharm

South Korea
arrow
PEGS Boston Summit
Not Confirmed

Hyundai Pharm

South Korea
arrow
PEGS Boston Summit
Not Confirmed

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

Product Name : Undisclosed

Product Type : Enzyme

Upfront Cash : Inapplicable

March 24, 2015

blank

Details:

Surfolase is a Enzyme drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Acebrophylline,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Enzyme

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 27, 2015

blank

05

Hyundai Pharm

South Korea
arrow
PEGS Boston Summit
Not Confirmed

Hyundai Pharm

South Korea
arrow
PEGS Boston Summit
Not Confirmed

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

Product Name : Undisclosed

Product Type : Enzyme

Upfront Cash : Inapplicable

February 27, 2015

blank

Details:

Surfolase is a Enzyme drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Acebrophylline,HT-002-01

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Enzyme

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 08, 2012

blank

06

Hyundai Pharm

South Korea
arrow
PEGS Boston Summit
Not Confirmed

Hyundai Pharm

South Korea
arrow
PEGS Boston Summit
Not Confirmed

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

Product Name : Undisclosed

Product Type : Enzyme

Upfront Cash : Inapplicable

November 08, 2012

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

read-more
read-more

01

Bracco

Italy
PEGS Boston Summit
Not Confirmed
arrow

Bracco

Italy
arrow
PEGS Boston Summit
Not Confirmed

Ambroxol-Theophylline-7-Acetate

Brand Name : Broncomnes

Dosage Form :

Dosage Strength : 30 Bust Grat 100 Mg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank

02

Bracco

Italy
PEGS Boston Summit
Not Confirmed
arrow

Bracco

Italy
arrow
PEGS Boston Summit
Not Confirmed

Ambroxol-Theophylline-7-Acetate

Brand Name : Broncomnes

Dosage Form :

Dosage Strength : The Scir 200 Ml 10 Mg/Ml  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank

03

PEGS Boston Summit
Not Confirmed
arrow
arrow
PEGS Boston Summit
Not Confirmed

Acebrophylline

Brand Name :

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

04

PEGS Boston Summit
Not Confirmed
arrow
arrow
PEGS Boston Summit
Not Confirmed

Ambroxol-Theophylline-7-Acetate

Brand Name :

Dosage Form : CAPSULE

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

blank

05

ZRS LABS

India
PEGS Boston Summit
Not Confirmed
arrow

ZRS LABS

India
arrow
PEGS Boston Summit
Not Confirmed

Acebrophylline

Brand Name :

Dosage Form : Capsule

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

06

ZRS LABS

India
PEGS Boston Summit
Not Confirmed
arrow

ZRS LABS

India
arrow
PEGS Boston Summit
Not Confirmed

Acebrophylline

Brand Name :

Dosage Form : SR Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

07

Country
PEGS Boston Summit
Not Confirmed
arrow

Country
arrow
PEGS Boston Summit
Not Confirmed

Ambroxol-Theophylline-7-Acetate

Brand Name : Ambromucil

Dosage Form :

Dosage Strength : 30 Bust Grat 100 Mg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank

08

Country
PEGS Boston Summit
Not Confirmed
arrow

Country
arrow
PEGS Boston Summit
Not Confirmed

Ambroxol-Theophylline-7-Acetate

Brand Name : Surfolase

Dosage Form :

Dosage Strength : To 30 Bust Grat 100 Mg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank

09

Country
PEGS Boston Summit
Not Confirmed
arrow

Country
arrow
PEGS Boston Summit
Not Confirmed

Ambroxol-Theophylline-7-Acetate

Brand Name : Ambromucil

Dosage Form :

Dosage Strength : The Scir 200 Ml 10 Mg/Ml  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank

10

Country
PEGS Boston Summit
Not Confirmed
arrow

Country
arrow
PEGS Boston Summit
Not Confirmed

Ambroxol-Theophylline-7-Acetate

Brand Name : Surfolase

Dosage Form :

Dosage Strength : The Scir 200 Ml 1%  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Global Sales Information

Do you need Business Intel? Ask us

Market Place

Do you need sourcing support? Ask us

ABOUT THIS PAGE

Looking for 96989-76-3 / Acebrophylline API manufacturers, exporters & distributors?

Acebrophylline manufacturers, exporters & distributors 1

87

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

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

API | Excipient name

Acebrophylline

Synonyms

Ambroxol acefyllinate, Ambromucil, Broncomnes, Surfolase, 96989-76-3, Ambroxol theophyllinacetate

Cas Number

96989-76-3

Unique Ingredient Identifier (UNII)

0HM1E174TN

Acebrophylline Manufacturers

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

Acebrophylline Suppliers

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

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

Acebrophylline KDMF

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

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

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

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

Acebrophylline WC

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

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

Acebrophylline GMP

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

Acebrophylline CoA

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

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

Acebrophylline may be tested according to a variety of international standards, such as European Pharmacopoeia (Acebrophylline EP), Acebrophylline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acebrophylline 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty