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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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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"200000","totalValueFC":"4050.2","currency":"USD","unitRateINR":"16880000","date":"02-May-2024","totalValueINR":"337600","totalValueInUsd":"4050.2","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"3306636","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"MANUEL POMBO ANGULO,28,3RD FLOOR 28050 MADRID SPAIN Madrid, , SpainSDNF Spain","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715625000,"product":"NOT MICRONIZED FORMOTEROL FUMARATE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"60","unit":"GMS","unitRateFc":"110","totalValueFC":"6678.8","currency":"USD","unitRateINR":"9278.5","date":"14-May-2024","totalValueINR":"556710","totalValueInUsd":"6678.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29242970","bill_no":"1001749","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717525800,"product":"FORMOTEROL FUMARATE (BATCH NO.P-126M) (15 GMS) FORMOTEROL FUMARATE DIHYDRATE","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.015","unit":"KGS","unitRateFc":"176000","totalValueFC":"2925.3","currency":"EUR","unitRateINR":"16280000","date":"05-Jun-2024","totalValueINR":"244200","totalValueInUsd":"2925.3","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"3844348","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"AREA INDUSTRIAL DEL LIOBREGAT C\/ARGENT, 1 08755 CASTELBISBAL BARCELONASPAIN Barcelona, , Spain Spain","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718044200,"product":"FORMOTEROL FUMARATE (IUPAC NAME N-(2-HYDROXY-5-(1-HYDROXY-2-((1-(4-METHOXYPHENYL)PROPAN-2-YL)AMINO)ETHYL)PHENYL)FORMAMID","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"135000","totalValueFC":"272654","currency":"USD","unitRateINR":"11380500","date":"11-Jun-2024","totalValueINR":"22761000","totalValueInUsd":"272654","indian_port":"Indore-EPZ\/SEZ","hs_no":"29420090","bill_no":"1004147","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722191400,"product":"FORMOTEROL FUMARATE (IUPAC NAME N-(2-HYDROXY-5-(1-HYDROXY-2-((1-(4-METHOXYPHENYL)PROPAN-2-YL)AMINO)ETHYL)PHENYL)FORMAMID","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"135000","totalValueFC":"273097.3","currency":"USD","unitRateINR":"11414250","date":"29-Jul-2024","totalValueINR":"22828500","totalValueInUsd":"273097.3","indian_port":"Indore-EPZ\/SEZ","hs_no":"29420090","bill_no":"1005513","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722364200,"product":"FORMOTEROL FUMARATE","address":"159, C.S.T. ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"XXKE XXA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"0.27","actualQuantity":"266","unit":"GMS","unitRateFc":"148","totalValueFC":"39823.1","currency":"USD","unitRateINR":"12514.5","date":"31-Jul-2024","totalValueINR":"3328857","totalValueInUsd":"39823.1","indian_port":"Indore-EPZ\/SEZ","hs_no":"29242990","bill_no":"1005578","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"159, C.S.T. ROAD,"}]
    04-Jan-2021
    25-Oct-2024
    KGS
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    Drugs in Development

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

    Mankind Pharma to Acquire Combihale and Daffy Brands From Dr Reddy's Laboratories

    Details:

    The acquisition of “Combihale” is expected to strengthen Mankind’s presence in the inhalation respiratory market segment. Daffy is a soap-free moisturising bar for infant babies.


    Lead Product(s): Formoterol Fumarate,Fluticasone Propionate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Combihale

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Mankind Pharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Acquisition February 16, 2022

    Dr Reddy Company Banner

    01

    Dr. Reddy's Laboratories

    India
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    Not Confirmed
    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Lead Product(s) : Formoterol Fumarate,Fluticasone Propionate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Mankind Pharma

    Deal Size : Undisclosed

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Mankind Pharma to Acquire Combihale and Daffy Brands From Dr Reddy's Laboratories

    Details : The acquisition of “Combihale” is expected to strengthen Mankind’s presence in the inhalation respiratory market segment. Daffy is a soap-free moisturising bar for infant babies.

    Brand Name : Combihale

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    February 16, 2022

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    Virtual Booth

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    Virtual BoothAucta is a global brand that creates better products from proven molecules.

    Aucta Announces FDA Approval Of A Generic Version Of Perforomist® (formoterol fumarate) Inhalation Solution

    Details:

    Formoterol Fumarate is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema).


    Lead Product(s): Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Formoterol Fumarate-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 01, 2022

    Aucta Company Banner

    02

    Aucta Pharmaceuticals

    U.S.A
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    Attending
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    Virtual BoothAucta is a global brand that creates better products from proven molecules.

    Lead Product(s) : Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aucta Announces FDA Approval Of A Generic Version Of Perforomist® (formoterol fumarate) Inhalatio...

    Details : Formoterol Fumarate is a long-acting bronchodilator used as a long-term treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchiti...

    Brand Name : Formoterol Fumarate-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 01, 2022

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    Virtual Booth

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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.

    AstraZeneca Pharma Pharma India to launch Breztri Aerosphere in Jan 2025

    Details:

    Breztri Aerosphere is a combination of budesonide, glycopyrrolate and formoterol fumarate indicated for the maintenance treatment of patients with COPD.


    Lead Product(s): Budesonide,Glycopyrronium Bromide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Breztri Aerosphere

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 23, 2024

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    03

    AstraZeneca

    United Kingdom
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    Not Confirmed

    AstraZeneca

    United Kingdom
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    Not Confirmed
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    Lead Product(s) : Budesonide,Glycopyrronium Bromide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AstraZeneca Pharma Pharma India to launch Breztri Aerosphere in Jan 2025

    Details : Breztri Aerosphere is a combination of budesonide, glycopyrrolate and formoterol fumarate indicated for the maintenance treatment of patients with COPD.

    Brand Name : Breztri Aerosphere

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 23, 2024

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    Mundipharma, Vectura Plan to Reformulate flutiform® to Reduce Carbon Footprint

    Details:

    Two companies have a collaboration agreement to develop an environmentally friendly propellant for flutiform® (fluticasone propionate/formoterol fumarate) in a pMDI formulation.


    Lead Product(s): Fluticasone Propionate,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Flutiform

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Vectura Ltd

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration April 16, 2024

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    Mundipharma

    Germany
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    Not Confirmed

    Mundipharma

    Germany
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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.

    Lead Product(s) : Fluticasone Propionate,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Vectura Ltd

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Mundipharma, Vectura Plan to Reformulate flutiform® to Reduce Carbon Footprint

    Details : Two companies have a collaboration agreement to develop an environmentally friendly propellant for flutiform® (fluticasone propionate/formoterol fumarate) in a pMDI formulation.

    Brand Name : Flutiform

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    April 16, 2024

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    Mankind Pharma Enters Exclusive Pact to Distribute AstraZeneca's Symbicort in India

    Details:

    Under the agreement, Mankind Pharma will distribute AstraZeneca's anti-asthma inhaled corticosteroid drug Symbicort, (budesonide/formoterol) approved to treat asthma and COPD, in India.


    Lead Product(s): Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Symbicort

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Mankind Pharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement March 13, 2024

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    AstraZeneca

    United Kingdom
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    Not Confirmed

    AstraZeneca

    United Kingdom
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    Not Confirmed
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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.

    Lead Product(s) : Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Mankind Pharma

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Mankind Pharma Enters Exclusive Pact to Distribute AstraZeneca's Symbicort in India

    Details : Under the agreement, Mankind Pharma will distribute AstraZeneca's anti-asthma inhaled corticosteroid drug Symbicort, (budesonide/formoterol) approved to treat asthma and COPD, in India.

    Brand Name : Symbicort

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    March 13, 2024

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    Viatris Announces Launch of Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the First FDA-Approved Generic Version of Symbi...

    Details:

    Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol is the first generic version of AstraZeneca's Symbicort drug-device combination product and is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).


    Lead Product(s): Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Breyna

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 31, 2023

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    Viatris

    U.S.A
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    Not Confirmed

    Viatris

    U.S.A
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    Not Confirmed
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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.

    Lead Product(s) : Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Viatris Announces Launch of Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Ae...

    Details : Breyna™ (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol is the first generic version of AstraZeneca's Symbicort drug-device combination product and is indicated for certain patients with asthma or chronic obstructive pulmonary disease...

    Brand Name : Breyna

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 31, 2023

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    Covis Pharma Announces Positive Topline Results from the AVANT Phase 3 Clinical Trial Showing Significant Improvement in Patients with Moderate to Sever...

    Details:

    Duaklir (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a LAMA and Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA).


    Lead Product(s): Aclidinium Bromide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Duaklir

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 25, 2022

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    07

    Covis Pharma

    Luxembourg
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    Not Confirmed

    Covis Pharma

    Luxembourg
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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.

    Lead Product(s) : Aclidinium Bromide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Covis Pharma Announces Positive Topline Results from the AVANT Phase 3 Clinical Trial Showing Sign...

    Details : Duaklir (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a LAMA and Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2...

    Brand Name : Duaklir

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 25, 2022

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    Lupin's Arm Gets UK Regulator Nod for COPD Treatment

    Details:

    Luforbec (formoterol) oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease.


    Lead Product(s): Formoterol Fumarate,Beclomethasone Dipropionate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Luforbec

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 25, 2022

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    08

    Lupin Ltd

    India
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    Not Confirmed

    Lupin Ltd

    India
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    Not Confirmed
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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.

    Lead Product(s) : Formoterol Fumarate,Beclomethasone Dipropionate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin's Arm Gets UK Regulator Nod for COPD Treatment

    Details : Luforbec (formoterol) oral inhalation is used to control wheezing, shortness of breath, and chest tightness caused by chronic obstructive pulmonary disease.

    Brand Name : Luforbec

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 25, 2022

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    #PipelineProspector

    Data Compilation
    #PharmaFlow

    Virtual Booth

    • Development Update
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    Viatris Inc. Announces Receipt of the First FDA Approval for Generic Version of Symbicort® Inhalation Aerosol, Breyna™ (Budesonide and Formoterol Fum...

    Details:

    Breyna (Budesonide and Formoterol Fumarate Dihydrate), first approved generic version of AstraZeneca's Symbicort, a drug-device combination product, is indicated for certain patients with asthma or COPD and will be available in 160 /4.5 and 80/4.5 mcg dosage strengths.


    Lead Product(s): Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Breyna

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Kindeva Drug Delivery

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 16, 2022

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    09

    Viatris

    U.S.A
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    Antibody Engineering
    Not Confirmed

    Viatris

    U.S.A
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    Antibody Engineering
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    Lead Product(s) : Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Kindeva Drug Delivery

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Viatris Inc. Announces Receipt of the First FDA Approval for Generic Version of Symbicort® Inhala...

    Details : Breyna (Budesonide and Formoterol Fumarate Dihydrate), first approved generic version of AstraZeneca's Symbicort, a drug-device combination product, is indicated for certain patients with asthma or COPD and will be available in 160 /4.5 and 80/4.5 mcg do...

    Brand Name : Breyna

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 16, 2022

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    FDA Approves First Generic of Symbicort to Treat Asthma and COPD

    Details:

    U.S.FDA approved generic budesonide and formoterol fumarate dihydrate aerosol for treatment of two pulmonary health conditions: asthma in patients six years of age and older; and maintenance treatment of airflow obstruction and reducing exacerbations for patients with COPD.


    Lead Product(s): Budesonide,Formoterol Fumarate

    Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Budesonide/Formoterol Fumarate Dihydrate-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 15, 2022

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    10

    Viatris

    U.S.A
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    Antibody Engineering
    Not Confirmed

    Viatris

    U.S.A
    arrow
    Antibody Engineering
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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.

    Lead Product(s) : Budesonide,Formoterol Fumarate

    Therapeutic Area : Pulmonary/Respiratory Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    FDA Approves First Generic of Symbicort to Treat Asthma and COPD

    Details : U.S.FDA approved generic budesonide and formoterol fumarate dihydrate aerosol for treatment of two pulmonary health conditions: asthma in patients six years of age and older; and maintenance treatment of airflow obstruction and reducing exacerbations for...

    Brand Name : Budesonide/Formoterol Fumarate Dihydrate-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 15, 2022

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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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