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    Chemistry

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    Also known as: Mls001401438, Chembl1895091, Hms2051p14, Hms2233m10, Ccg-101038, Nc00288
    Molecular Formula
    C23H30N2O9
    Molecular Weight
    478.5  g/mol
    InChI Key
    AXAGNMKWGBWLMO-GQMFVQBYSA-N
    Formoterol Fumarate
    1 2D Structure

    Formoterol Fumarate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (E)-but-2-enedioic acid;N-[2-hydroxy-5-[(1S)-1-hydroxy-2-[[(2S)-1-(4-methoxyphenyl)propan-2-yl]amino]ethyl]phenyl]formamide;hydrate
    2.1.2 InChI
    InChI=1S/C19H24N2O4.C4H4O4.H2O/c1-13(9-14-3-6-16(25-2)7-4-14)20-11-19(24)15-5-8-18(23)17(10-15)21-12-22;5-3(6)1-2-4(7)8;/h3-8,10,12-13,19-20,23-24H,9,11H2,1-2H3,(H,21,22);1-2H,(H,5,6)(H,7,8);1H2/b;2-1+;/t13-,19+;;/m0../s1
    2.1.3 InChI Key
    AXAGNMKWGBWLMO-GQMFVQBYSA-N
    2.1.4 Canonical SMILES
    CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C(C=C2)O)NC=O)O.C(=CC(=O)O)C(=O)O.O
    2.1.5 Isomeric SMILES
    C[C@@H](CC1=CC=C(C=C1)OC)NC[C@H](C2=CC(=C(C=C2)O)NC=O)O.C(=C/C(=O)O)\C(=O)O.O
    2.2 Synonyms
    2.2.1 Depositor-Supplied Synonyms

    1. Mls001401438

    2. Chembl1895091

    3. Hms2051p14

    4. Hms2233m10

    5. Ccg-101038

    6. Nc00288

    7. Smr000471620

    2.3 Create Date
    2007-12-08
    3 Chemical and Physical Properties
    Molecular Weight 478.5 g/mol
    Molecular Formula C23H30N2O9
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count10
    Exact Mass478.19513054 g/mol
    Monoisotopic Mass478.19513054 g/mol
    Topological Polar Surface Area166 Ų
    Heavy Atom Count34
    Formal Charge0
    Complexity507
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3

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    06-Jan-2022
    28-Oct-2025
    KGS
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    Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma

    Details:

    Lunsekimig is a Protein drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Asthma.


    Lead Product(s): Lunsekimig,Fluticasone Propionate,Salmeterol Xinafoate,Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Protein

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 06, 2024

    Sanofi Company Banner

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    Sanofi

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Lunsekimig,Fluticasone Propionate,Salmeterol Xinafoate,Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma

    Details : Lunsekimig is a Protein drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Asthma.

    Product Name : Undisclosed

    Product Type : Protein

    Upfront Cash : Inapplicable

    November 06, 2024

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

    Details:

    Dupilumab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Asthma.


    Lead Product(s): Dupilumab,Fluticasone Propionate,Salmeterol Xinafoate,Budesonide,Formoterol Fumarate,Mometasone Furoate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Antibody, Unconjugated

    Sponsor: Regeneron Pharmaceuticals

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 09, 2015

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    Sanofi

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Dupilumab,Fluticasone Propionate,Salmeterol Xinafoate,Budesonide,Formoterol Fumarate,Mometasone Furoate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

    Details : Dupilumab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Asthma.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    October 09, 2015

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

    Details:

    Dupilumab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Asthma.


    Lead Product(s): Dupilumab,Mometasone Furoate,Formoterol Fumarate,Salbutamol Sulphate,Levalbuterol Sulfate,Levalbuterol Hydrochloride

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Antibody, Unconjugated

    Sponsor: Regeneron Pharmaceuticals

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 15, 2013

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    Sanofi

    France
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Dupilumab,Mometasone Furoate,Formoterol Fumarate,Salbutamol Sulphate,Levalbuterol Sulfate,Levalbuterol Hydrochloride

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

    Details : Dupilumab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Asthma.

    Product Name : Undisclosed

    Product Type : Antibody, Unconjugated

    Upfront Cash : Inapplicable

    May 15, 2013

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    Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

    Details:

    Budesonide is a Steroid drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Asthma.


    Lead Product(s): Budesonide,Formoterol Fumarate,Carbon

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Steroid

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 08, 2017

    Fermion Orion Company Banner

    04

    Orion Corporation

    Finland
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    Lead Product(s) : Budesonide,Formoterol Fumarate,Carbon

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pharmacokinetic Study to Compare Absorption of Budesonide/Formoterol Easyhaler and Symbicort Turbu...

    Details : Budesonide is a Steroid drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Asthma.

    Product Name : Undisclosed

    Product Type : Steroid

    Upfront Cash : Inapplicable

    March 08, 2017

    Fermion Orion Company Banner

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    To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product

    Details:

    Budesonide is a Steroid drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Asthma.


    Lead Product(s): Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Steroid

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 04, 2014

    Fermion Orion Company Banner

    05

    Orion Corporation

    Finland
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    Lead Product(s) : Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Produc...

    Details : Budesonide is a Steroid drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Asthma.

    Product Name : Undisclosed

    Product Type : Steroid

    Upfront Cash : Inapplicable

    December 04, 2014

    Fermion Orion Company Banner

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    Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers

    Details:

    Budesonide is a Steroid drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Asthma.


    Lead Product(s): Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Steroid

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 17, 2012

    Fermion Orion Company Banner

    06

    Orion Corporation

    Finland
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    Lead Product(s) : Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers

    Details : Budesonide is a Steroid drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Asthma.

    Product Name : Undisclosed

    Product Type : Steroid

    Upfront Cash : Inapplicable

    August 17, 2012

    Fermion Orion Company Banner

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    Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte

    Details:

    Budesonide is a Steroid drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Asthma.


    Lead Product(s): Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Steroid

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 25, 2012

    Fermion Orion Company Banner

    07

    Orion Corporation

    Finland
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    Lead Product(s) : Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte

    Details : Budesonide is a Steroid drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Asthma.

    Product Name : Undisclosed

    Product Type : Steroid

    Upfront Cash : Inapplicable

    June 25, 2012

    Fermion Orion Company Banner

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    Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

    Details:

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


    Lead Product(s): Carbon,Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 08, 2012

    Fermion Orion Company Banner

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    Orion Corporation

    Finland
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    Lead Product(s) : Carbon,Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Comparison of Absorption of Budesonide and Formoterol From Budesonide/Formoterol Easyhaler and Sym...

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

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 08, 2012

    Fermion Orion Company Banner

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    Pharmacokinetic Pilot Study on Budesonide/Formoterol

    Details:

    Budesonide is a Steroid drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.


    Lead Product(s): Budesonide,Formoterol Fumarate

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Steroid

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 24, 2011

    Fermion Orion Company Banner

    09

    Orion Corporation

    Finland
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    Lead Product(s) : Budesonide,Formoterol Fumarate

    Therapeutic Area : Undisclosed

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pharmacokinetic Pilot Study on Budesonide/Formoterol

    Details : Budesonide is a Steroid drug candidate, which is currently being evaluated in clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Steroid

    Upfront Cash : Inapplicable

    October 24, 2011

    Fermion Orion Company Banner

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    Phase I Pharmacokinetic Study (BF-BLOCK)

    Details:

    Budesonide is a Steroid drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Asthma.


    Lead Product(s): Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Steroid

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 25, 2011

    Fermion Orion Company Banner

    10

    Orion Corporation

    Finland
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    Lead Product(s) : Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Phase I Pharmacokinetic Study (BF-BLOCK)

    Details : Budesonide is a Steroid drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Asthma.

    Product Name : Undisclosed

    Product Type : Steroid

    Upfront Cash : Inapplicable

    August 25, 2011

    Fermion Orion Company Banner

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    INTERMEDIATE SUPPLIERS

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    01

    Vamsi Labs

    India
    DCAT
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    Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

    Alpha-bromo-4-benzoloxy-3- nitroacetophenone

    CAS Number : 43229-01-2

    End Use API : Formoterol Fumarate

    About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domesti...

    Vamsi Labs

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    02

    Vamsi Labs

    India
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    Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

    (4-Methoxy phenyl)-iso propyl benzyl amine hydroch...

    CAS Number : 1049695-95-5

    End Use API : Formoterol Fumarate

    About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domesti...

    Vamsi Labs

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    03

    Vamsi Labs

    India
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    Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

    Benzyl formoterol free base

    CAS Number : 43229-70-5

    End Use API : Formoterol Fumarate

    About The Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domesti...

    Vamsi Labs

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    04

    Fermion Oy

    Finland
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    Virtual BoothWith Fermion, start the journey of your innovative API.

    N-(2-hydroxy-5-((RS)-1-hydroxy-2-(((RS)-1-(4-metho...

    CAS Number : 73573-87-2

    End Use API : Formoterol Fumarate

    About The Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services co...

    fermion

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    05

    Jinan Tantu Chemicals

    China
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    Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

    N-Benzyl-N-methylethanolamine

    CAS Number : 101-98-4

    End Use API : Formoterol Fumarate

    About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

    Jinan Tantu Chemicals

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    06

    GANGWAL CHEMICALS PVT LTD

    India
    CTAD25
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    GANGWAL CHEMICALS PVT LTD

    India
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    4-Benzyloxy-3-Nitro-Alpha-[N-benzyl-N-[1-methyl-2-...

    CAS Number :

    End Use API : Formoterol Fumarate

    About The Company : Gangwal is a progressive and innovative business group with a clear vision and ascertaining new challenges, having a strong foundation supported by strong pilla...

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    07

    GANGWAL CHEMICALS PVT LTD

    India
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    GANGWAL CHEMICALS PVT LTD

    India
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    N-O-Dibenzyl Formoterol

    CAS Number :

    End Use API : Formoterol Fumarate

    About The Company : Gangwal is a progressive and innovative business group with a clear vision and ascertaining new challenges, having a strong foundation supported by strong pilla...

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    08

    Hiray Pharma Solutions

    China
    CTAD25
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    Hiray Pharma Solutions

    China
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    2-Bromo-4'-Benzyloxy-3'-nitroacetophenone

    CAS Number : 43229-01-2

    End Use API : Formoterol Fumarate

    About The Company : Hiray Pharma Solutions is an international end-to-end CDMO, facilitating the development and manufacturing of important drug products and key intermediates arou...

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    09

    Progress Life Sciences

    India
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    Progress Life Sciences

    India
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    4-Hydroxy-3"-nitroacetophenone

    CAS Number : 6322-56-1

    End Use API : Formoterol Fumarate

    About The Company : Progress is a company led by professionals, established by technocrats with a vision for global business expansion. Our headquarters are located in Vashi, Mumba...

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    10

    SLN Pharmachem

    India
    CTAD25
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    SLN Pharmachem

    India
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    2-Bromo-4’-Benzyloxy-3’-Nitro Acetophenone

    CAS Number : 43229-01-2

    End Use API : Formoterol Fumarate

    About The Company : SLN Pharmachem was setup in 1997 with an objective to provide technology based products (Intermediates) for Pharmaceutical, Cosmetic and Fine Chemical Industry....

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    FDA Orange Book

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    01

    DR REDDYS

    India
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    RLD : No

    TE Code : AN

    FORMOTEROL FUMARATE

    Brand Name : FORMOTEROL FUMARATE

    Dosage Form : SOLUTION;INHALATION

    Dosage Strength : 0.02MG/2ML

    Approval Date : 2025-01-30

    Application Number : 215907

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AN

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    02

    MANKIND PHARMA

    India
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    CPhI Middle East
    Exhibiting
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    • WHO-GMP

    Virtual BoothDelivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.

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    RLD : No

    TE Code : AN

    FORMOTEROL FUMARATE

    Brand Name : FORMOTEROL FUMARATE

    Dosage Form : SOLUTION;INHALATION

    Dosage Strength : 0.02MG/2ML

    Approval Date : 2023-03-22

    Application Number : 215883

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AN

    Company Banner

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    03

    ASTRAZENECA

    United Kingdom
    CTAD25
    Not Confirmed
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    ASTRAZENECA

    United Kingdom
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    CTAD25
    Not Confirmed
    • fda
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    RLD : Yes

    TE Code :

    FORMOTEROL FUMARATE; GLYCOPYRROLATE

    Brand Name : BEVESPI AEROSPHERE

    Dosage Form : AEROSOL, METERED;INHALATION

    Dosage Strength : 0.0048MG/INH;0.0090MG/INH

    Approval Date : 2016-04-25

    Application Number : 208294

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    ASTRAZENECA AB

    United Kingdom
    CTAD25
    Not Confirmed
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    ASTRAZENECA AB

    United Kingdom
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    CTAD25
    Not Confirmed
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    RLD : Yes

    TE Code :

    BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

    Brand Name : BREZTRI AEROSPHERE

    Dosage Form : AEROSOL, METERED;INHALATION

    Dosage Strength : 0.16MG/INH;0.0048MG/INH;0.009MG/INH

    Approval Date : 2020-07-23

    Application Number : 212122

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    05

    COVIS

    Luxembourg
    CTAD25
    Not Confirmed
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    COVIS

    Luxembourg
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    CTAD25
    Not Confirmed
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    RLD : Yes

    TE Code :

    ACLIDINIUM BROMIDE; FORMOTEROL FUMARATE

    Brand Name : DUAKLIR PRESSAIR

    Dosage Form : POWDER, METERED;INHALATION

    Dosage Strength : 0.4MG/INH;0.012MG/INH

    Approval Date : 2019-03-29

    Application Number : 210595

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    06

    DEVA HOLDING AS

    Turkey
    CTAD25
    Not Confirmed
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    DEVA HOLDING AS

    Turkey
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    CTAD25
    Not Confirmed
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    RLD : No

    TE Code : AN

    FORMOTEROL FUMARATE

    Brand Name : FORMOTEROL FUMARATE

    Dosage Form : SOLUTION;INHALATION

    Dosage Strength : 0.02MG/2ML

    Approval Date : 2025-02-11

    Application Number : 218308

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AN

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    07

    LUPIN

    India
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    CPhI Milan
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    RLD : No

    TE Code : AN

    FORMOTEROL FUMARATE

    Brand Name : FORMOTEROL FUMARATE

    Dosage Form : SOLUTION;INHALATION

    Dosage Strength : 0.02MG/2ML

    Approval Date : 2022-08-22

    Application Number : 215053

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AN

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    08

    MICRO LABS

    India
    CTAD25
    Not Confirmed
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    MICRO LABS

    India
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    CTAD25
    Not Confirmed
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    • WHO-GMP
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    Digital Content Digital Content

    RLD : No

    TE Code : AN

    FORMOTEROL FUMARATE

    Brand Name : FORMOTEROL FUMARATE

    Dosage Form : SOLUTION;INHALATION

    Dosage Strength : 0.02MG/2ML

    Approval Date : 2024-06-26

    Application Number : 218304

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AN

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    09

    TEVA PHARMS USA INC

    Israel
    CTAD25
    Not Confirmed
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    TEVA PHARMS USA INC

    Israel
    arrow
    CTAD25
    Not Confirmed
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    Digital Content Digital Content

    RLD : No

    TE Code : AN

    FORMOTEROL FUMARATE

    Brand Name : FORMOTEROL FUMARATE

    Dosage Form : SOLUTION;INHALATION

    Dosage Strength : 0.02MG/2ML

    Approval Date : 2021-06-22

    Application Number : 91141

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AN

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    10

    MYLAN

    U.S.A
    CTAD25
    Not Confirmed
    arrow

    MYLAN

    U.S.A
    arrow
    CTAD25
    Not Confirmed
    • fda
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : No

    TE Code : AB

    BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

    Brand Name : BREYNA

    Dosage Form : AEROSOL, METERED;INHALATION

    Dosage Strength : 0.08MG/INH;0.0045MG/INH

    Approval Date : 2022-03-15

    Application Number : 211699

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Europe

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    01

    ORION CORPORATION

    Finland
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    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Italy

    Budesonide; Formoterol

    Brand Name : Fobuler

    Dosage Form : Budesonide+Formoterol+4,5160 Mcg 120 Doses Respiratory Use + Easyhaler

    Dosage Strength : easyhaler groun inhal 120 doses 160 mcg + 4.5 mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Fermion Orion Company Banner

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    02

    Orion Corporation - Espoo

    Finland
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    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Norway

    Formoterol; Budesonide

    Brand Name : Bufomix Easy Tails

    Dosage Form : Inhalasjonspulver

    Dosage Strength : 160MCG/Dose; 4.5MCG/Dose

    Packaging : Inhalator

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

    Fermion Orion Company Banner

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    03

    ORION CORPORATION

    Finland
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    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Italy

    Budesonide; Formoterol

    Brand Name : FOBULER

    Dosage Form : Inhalation Powder For Pre-Dosed Inhalation

    Dosage Strength : 160 micrograms/4.5 micrograms

    Packaging : 120 DOSES (160+4.5) MCG - RESPIRATORY USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

    Fermion Orion Company Banner

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    04

    Orion Corporation

    Finland
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    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Approved

    Registration Country : Sweden

    Budesonide; Formoterol Fumarate Dihydrate

    Brand Name : Bufar Easyhaler

    Dosage Form : Inhalation Powder

    Dosage Strength : 80mcg/4.5mcg/inhalation

    Packaging :

    Approval Date : 31/03/2016

    Application Number : 20150416000027

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    05

    Orion Corporation

    Finland
    arrow
    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    Regulatory Info : Approved

    Registration Country : Sweden

    Budesonide; Formoterol Fumarate Dihydrate

    Brand Name : Bufori Easyhaler

    Dosage Form : Inhalation Powder

    Dosage Strength : 80mcg/4.5mcg/inhalation

    Packaging :

    Approval Date : 02/11/2016

    Application Number : 20151205000013

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    06

    Orion Corporation

    Finland
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    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Approved

    Registration Country : Sweden

    Budesonide; Formoterol Fumarate Dihydrate

    Brand Name : Bufoler Easyhaler

    Dosage Form : Inhalation Powder

    Dosage Strength : 160mcg/dose;4.5mcg/dose

    Packaging :

    Approval Date : 22/01/2016

    Application Number : 20150207000021

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    07

    Orion Corporation

    Finland
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    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    Regulatory Info : Approved

    Registration Country : Sweden

    Budesonide; Formoterol Fumarate Dihydrate

    Brand Name : Bufori Easyhaler

    Dosage Form : Inhalation Powder

    Dosage Strength : 160mcg/dose;4.5mcg/dose

    Packaging :

    Approval Date : 02/11/2016

    Application Number : 20151205000020

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    08

    Orion Corporation

    Finland
    arrow
    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    Regulatory Info : Deregistered

    Registration Country : Sweden

    Budesonide; Formoterol Fumarate Dihydrate

    Brand Name : Fobumix Easyhaler

    Dosage Form : Inhalation Powder

    Dosage Strength : 80mcg/4.5mcg/inhalation

    Packaging :

    Approval Date : 13/01/2017

    Application Number : 20160130000029

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    09

    Orion Corporation

    Finland
    arrow
    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    Regulatory Info : Approved

    Registration Country : Sweden

    Budesonide; Formoterol Fumarate Dihydrate

    Brand Name : Bufoler Easyhaler

    Dosage Form : Inhalation Powder

    Dosage Strength : 320mcg/dose;9mcg/dose

    Packaging :

    Approval Date : 22/01/2016

    Application Number : 20150207000038

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    10

    Orion Corporation

    Finland
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    CTAD25
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Regulatory Info : Withdrawn

    Registration Country : Malta

    Budesonide; Formoterol Fumarate Dihydrate

    Brand Name : Bufomix Easyhaler Inhalation Powder

    Dosage Form : Inhalation Powder

    Dosage Strength : 80MCG; 4.5MCG

    Packaging :

    Approval Date : 2016-07-05

    Application Number :

    Regulatory Info : Withdrawn

    Registration Country : Malta

    Fermion Orion Company Banner

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - POWDER;INHALATION - 0.012MG/INH **Fe...DOSAGE - POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20831

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    DOSAGE - POWDER, METERED;INHALATION - 0.4MG/I...DOSAGE - POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH

    USFDA APPLICATION NUMBER - 210595

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH

    USFDA APPLICATION NUMBER - 21929

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH

    USFDA APPLICATION NUMBER - 21929

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH

    USFDA APPLICATION NUMBER - 22518

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH

    USFDA APPLICATION NUMBER - 22518

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    DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH

    USFDA APPLICATION NUMBER - 22518

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    EDQM

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    01

    EDQM, Council of Europe

    Formoterol fumarate for system suitabili...

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    CTAD25
    Not Confirmed

    01

    EDQM, Council of Europe

    France
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    CTAD25
    Not Confirmed

    Formoterol fumarate for system suitability

    CAS Number : 43229-80-7

    Quantity Per Vial : 10 mg

    Sale Unit : 1

    Order Code : Y0000340

    Batch No : 2

    Price (€) : 79

    Storage : +5°C ± 3°C

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    EDQM, Council of Europe

    Formoterol for impurity I identification

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    CTAD25
    Not Confirmed

    02

    EDQM, Council of Europe

    France
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    CTAD25
    Not Confirmed

    Formoterol for impurity I identification

    CAS Number : 43229-80-7

    Quantity Per Vial : 10 mg

    Sale Unit : 1

    Order Code : Y0000339

    Batch No : 2

    Price (€) : 79

    Storage : +5°C ± 3°C

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    03

    EDQM, Council of Europe

    Formoterol fumarate dihydrate

    arrow
    CTAD25
    Not Confirmed

    03

    EDQM, Council of Europe

    France
    arrow
    CTAD25
    Not Confirmed

    Formoterol fumarate dihydrate

    CAS Number : 43229-80-7

    Quantity Per Vial : 10 mg

    Sale Unit : 1

    Order Code : F0372000

    Batch No : 2

    Price (€) : 79

    Storage : +5°C ± 3°C

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    ABOUT THIS PAGE

    Looking for / Formoterol Fumarate API manufacturers, exporters & distributors?

    Formoterol Fumarate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Formoterol Fumarate

    Synonyms

    Mls001401438, Chembl1895091, Hms2051p14, Hms2233m10, Ccg-101038, Nc00288

    Formoterol Fumarate Dihydrate Manufacturers

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

    Formoterol Fumarate Dihydrate Suppliers

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

    click here to find a list of Formoterol Fumarate Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Formoterol Fumarate Dihydrate USDMF

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

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

    click here to find a list of Formoterol Fumarate Dihydrate suppliers with USDMF on PharmaCompass.

    Formoterol Fumarate Dihydrate JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Formoterol Fumarate Dihydrate Drug Master File in Japan (Formoterol Fumarate Dihydrate JDMF) empowers Formoterol Fumarate Dihydrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Formoterol Fumarate Dihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Formoterol Fumarate Dihydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Formoterol Fumarate Dihydrate suppliers with JDMF on PharmaCompass.

    Formoterol Fumarate Dihydrate KDMF

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

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

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

    click here to find a list of Formoterol Fumarate Dihydrate suppliers with KDMF on PharmaCompass.

    Formoterol Fumarate Dihydrate CEP

    A Formoterol Fumarate Dihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Formoterol Fumarate Dihydrate Certificate of Suitability (COS). The purpose of a Formoterol Fumarate Dihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Formoterol Fumarate Dihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Formoterol Fumarate Dihydrate to their clients by showing that a Formoterol Fumarate Dihydrate CEP has been issued for it. The manufacturer submits a Formoterol Fumarate Dihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Formoterol Fumarate Dihydrate CEP holder for the record. Additionally, the data presented in the Formoterol Fumarate Dihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Formoterol Fumarate Dihydrate DMF.

    A Formoterol Fumarate Dihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Formoterol Fumarate Dihydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Formoterol Fumarate Dihydrate suppliers with CEP (COS) on PharmaCompass.

    Formoterol Fumarate Dihydrate WC

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

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

    Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Formoterol Fumarate Dihydrate suppliers with NDC on PharmaCompass.

    Formoterol Fumarate Dihydrate GMP

    Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate GMP manufacturer or Formoterol Fumarate Dihydrate GMP API supplier for your needs.

    Formoterol Fumarate Dihydrate CoA

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

    Formoterol Fumarate Dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Formoterol Fumarate Dihydrate 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.

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