API Import of Indacaterol Acetate obtained from Indian Customs Trade Statistics

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Chemistry

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Also known as: 1000160-96-2, Ryi4401dtm, Indacaterol acetate (jan), Indacaterol acetate [jan], Acetic acid;5-[(1r)-2-[(5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-1h-quinolin-2-one, Unii-ryi4401dtm
Molecular Formula
C26H32N2O5
Molecular Weight
452.5  g/mol
InChI Key
HZHXFIDENGBQFQ-FTBISJDPSA-N
FDA UNII
RYI4401DTM

Indacaterol Acetate
1 2D Structure

Indacaterol Acetate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
acetic acid;5-[(1R)-2-[(5,6-diethyl-2,3-dihydro-1H-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-1H-quinolin-2-one
2.1.2 InChI
InChI=1S/C24H28N2O3.C2H4O2/c1-3-14-9-16-11-18(12-17(16)10-15(14)4-2)25-13-22(28)19-5-7-21(27)24-20(19)6-8-23(29)26-24;1-2(3)4/h5-10,18,22,25,27-28H,3-4,11-13H2,1-2H3,(H,26,29);1H3,(H,3,4)/t22-;/m0./s1
2.1.3 InChI Key
HZHXFIDENGBQFQ-FTBISJDPSA-N
2.1.4 Canonical SMILES
CCC1=C(C=C2CC(CC2=C1)NCC(C3=C4C=CC(=O)NC4=C(C=C3)O)O)CC.CC(=O)O
2.1.5 Isomeric SMILES
CCC1=C(C=C2CC(CC2=C1)NC[C@@H](C3=C4C=CC(=O)NC4=C(C=C3)O)O)CC.CC(=O)O
2.2 Other Identifiers
2.2.1 UNII
RYI4401DTM
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 1000160-96-2

2. Ryi4401dtm

3. Indacaterol Acetate (jan)

4. Indacaterol Acetate [jan]

5. Acetic Acid;5-[(1r)-2-[(5,6-diethyl-2,3-dihydro-1h-inden-2-yl)amino]-1-hydroxyethyl]-8-hydroxy-1h-quinolin-2-one

6. Unii-ryi4401dtm

7. Indacaterol Acetic

8. Schembl362019

9. Chembl4297657

10. Dtxsid70142865

11. Ex-a6068

12. Indacaterol Acetate [who-dd]

13. D11009

14. Q27288350

15. (r)-5-[2-(5,6-diethyl-indan-2-ylamino)-1-hydroxyethyl]-8-hydroxy-1h-quinolin-2-one Acetate

2.4 Create Date
2008-02-26
3 Chemical and Physical Properties
Molecular Weight 452.5 g/mol
Molecular Formula C26H32N2O5
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count6
Rotatable Bond Count6
Exact Mass452.23112213 g/mol
Monoisotopic Mass452.23112213 g/mol
Topological Polar Surface Area119 Ų
Heavy Atom Count33
Formal Charge0
Complexity620
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API Reference Price

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MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643308200,"product":"INDACATEROL ACETATE GRADE: IH","address":"FLAT NO.1003,10TH FLR,UNIQUE TOWER ,,S.V.ROAD,NR.KAMATH CLUB,GOREGAON","city":"MUMBAI,MAHARASHTRA","supplier":"MELODY HEALTHCARE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER OF","customerCountry":"BANGLADESH","quantity":"0.17","actualQuantity":"0.17","unit":"KGS","unitRateFc":"350000","totalValueFC":"58676.3","currency":"USD","unitRateINR":25711764.705882352,"date":"28-Jan-2022","totalValueINR":"4371000","totalValueInUsd":"58676.3","indian_port":"BOMBAY AIR","hs_no":"29181990","bill_no":"7790325","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"FLAT NO.1003,10TH FLR,UNIQUE TOWER ,,S.V.ROAD,NR.KAMATH CLUB,GOREGAON, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1656873000,"product":"INDACATEROL ACETATE GRADE: IH","address":"FLAT NO.1003,10TH FLR,UNIQUE TOWER ,,S.V.ROAD,NR.KAMATH CLUB,GOREGAON","city":"MUMBAI,MAHARASHTRA","supplier":"MELODY HEALTHCARE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"TO THE ORDER OF","customerCountry":"EGYPT","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"375000","totalValueFC":"7155.7","currency":"USD","unitRateINR":28450000,"date":"04-Jul-2022","totalValueINR":"569000","totalValueInUsd":"7155.7","indian_port":"BOMBAY AIR","hs_no":"29181990","bill_no":"2584931","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"FLAT NO.1003,10TH FLR,UNIQUE TOWER ,,S.V.ROAD,NR.KAMATH CLUB,GOREGAON, MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704825000,"product":"PHARMA.RAW MATERIAL,ACTIVE PHARMA INGREDIENT,PACKING DETAILS:1 X 0.008 KGS INDACATEROL ACETATE GRADE:IH CAS:1000160-96-2","address":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,","city":"MUMBAI, MAHARASHTRA","supplier":"MELODY HEALTHCARE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"AS PER INVOICE","customerCountry":"PAKISTAN","quantity":"0.01","actualQuantity":"0.008","unit":"KGS","unitRateFc":"424000","totalValueFC":"3330.5","currency":"USD","unitRateINR":34600357.5,"date":"10-Jan-2024","totalValueINR":"276802.86","totalValueInUsd":"3330.5","indian_port":"Bombay Air","hs_no":"29181990","bill_no":"6641880","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721068200,"product":"ACTIVE PHARMACEUTICALS INGREDIENT API(PHARMACEUTICALS RAW MATERIAL FOR PHARMA INDUSTRIES)PRODUCT-INDACATEROL ACETATE IH","address":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,","city":"MUMBAI, MAHARASHTRA","supplier":"MELODY HEALTHCARE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"AS PER INVOICE","customerCountry":"PAKISTAN","quantity":"0.06","actualQuantity":"0.06","unit":"KGS","unitRateFc":"375000","totalValueFC":"22210.7","currency":"USD","unitRateINR":30943583.333333336,"date":"16-Jul-2024","totalValueINR":"1856615","totalValueInUsd":"22210.7","indian_port":"Bombay Air","hs_no":"29181990","bill_no":"2469286","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723746600,"product":"ACTIVE PHARMACEUTICAL INGREDIENT API(PHARMACEUTICAL RAW MATERIAL FOR PHARMA INDUSTRIES)PRODUCT-INDACATEROL ACETATE IH","address":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,","city":"MUMBAI, MAHARASHTRA","supplier":"MELODY HEALTHCARE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"AS PER INVOICE","customerCountry":"BANGLADESH","quantity":"0.03","actualQuantity":"0.03","unit":"KGS","unitRateFc":"205000","totalValueFC":"6003.5","currency":"USD","unitRateINR":16785500,"date":"16-Aug-2024","totalValueINR":"503565","totalValueInUsd":"6003.5","indian_port":"Bombay Air","hs_no":"29181990","bill_no":"3231211","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724697000,"product":"ACTIVE PHARMACEUTICAL INGREDIENT API(PHARMACEUTICAL RAW MATERIAL FOR PHARMA INDUSTRIES)PRODUCT-INDACATEROL ACETATE IH","address":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,","city":"MUMBAI, MAHARASHTRA","supplier":"MELODY HEALTHCARE PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"AS PER INVOICE","customerCountry":"EGYPT","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"250000","totalValueFC":"24658.5","currency":"USD","unitRateINR":20683190,"date":"27-Aug-2024","totalValueINR":"2068319","totalValueInUsd":"24658.5","indian_port":"Bombay Air","hs_no":"29181990","bill_no":"3513013","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"FLAT,NO.505, 5TH FLR.,UNIQUE TOWER,, MUMBAI, MAHARASHTRA","customerAddress":""}]
15-May-2021
27-Aug-2024
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Drugs in Development

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Details:

QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.


Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 07, 2020

Skyepharma Company Banner

01

Vectura Ltd

United Kingdom
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Luxepack
Not Confirmed

Details : QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.

Brand Name : Enerzair Breezhaler

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 07, 2020

Skyepharma Company Banner

Details:

New post hoc analysis results from the phase III IRIDIUM study that suggests that using Enerzair Breezhaler as a step-up therapy from medium-dose LABA/ICS provides benefit beyond increasing ICS dose alone.


Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 03, 2021

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02

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : New post hoc analysis results from the phase III IRIDIUM study that suggests that using Enerzair Breezhaler as a step-up therapy from medium-dose LABA/ICS provides benefit beyond increasing ICS dose alone.

Brand Name : Enerzair Breezhaler

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 03, 2021

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Details:

Under the Agreement, Valeo will be responsible for medical and commercial activities for Enerzair® Breezhaler® and Atectura® Breezhaler® for an initial 8 year period.


Lead Product(s): Indacaterol Acetate,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Atectura Breezhaler

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Valeo Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement March 29, 2021

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03

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Under the Agreement, Valeo will be responsible for medical and commercial activities for Enerzair® Breezhaler® and Atectura® Breezhaler® for an initial 8 year period.

Brand Name : Atectura Breezhaler

Molecule Type : Small molecule

Upfront Cash : Undisclosed

March 29, 2021

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Details:

High-dose, once-daily Enerzair® Breezhaler® [IND/GLY/MF] reduced asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks.


Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 07, 2020

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04

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : High-dose, once-daily Enerzair® Breezhaler® [IND/GLY/MF] reduced asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks.

Brand Name : Enerzair Breezhaler

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 07, 2020

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Details:

Patients using Enerzair® and Atectura® Breezhaler® to manage their uncontrolled asthma in Japan will have the option to enroll in Propeller’s digital health platform to help manage their condition.


Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 26, 2020

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05

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Patients using Enerzair® and Atectura® Breezhaler® to manage their uncontrolled asthma in Japan will have the option to enroll in Propeller’s digital health platform to help manage their condition.

Brand Name : Enerzair Breezhaler

Molecule Type : Small molecule

Upfront Cash : Undisclosed

August 26, 2020

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Details:

European Commission approves once-daily Enerzair® Breezhaler® in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1.


Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 07, 2020

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06

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : European Commission approves once-daily Enerzair® Breezhaler® in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1.

Brand Name : Enerzair Breezhaler

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 07, 2020

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Details:

For the first time in Japan, a new digital device combining a sensor with the Breezhaler® inhaler is being made available. Announcement by Novartis Pharma K. K. highlights key milestone for once-daily Enerzair® (IND/GLY/MF) complete with new sensor-enabled Breezhaler® device.


Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 29, 2020

blank

07

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : For the first time in Japan, a new digital device combining a sensor with the Breezhaler® inhaler is being made available. Announcement by Novartis Pharma K. K. highlights key milestone for once-daily Enerzair® (IND/GLY/MF) complete with new sensor-ena...

Brand Name : Enerzair Breezhaler

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 29, 2020

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Details:

Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily Tio in improving quality of life in people with uncontrolled asthma.


Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2020

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08

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily Tio in improving quality of life in people with uncontrolled asthma.

Brand Name : Enerzair Breezhaler

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 05, 2020

blank

Details:

Decision supported by robust efficacy and safety data from Phase III IRIDIUM study, in which once-daily Enerzair® Breezhaler® resulted in statistically significant improvements in lung function.


Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Propeller Health

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 01, 2020

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09

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : Decision supported by robust efficacy and safety data from Phase III IRIDIUM study, in which once-daily Enerzair® Breezhaler® resulted in statistically significant improvements in lung function.

Brand Name : Enerzair Breezhaler

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 01, 2020

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Details:

If the EC follows this recommendation and approves Enerzair® Breezhaler®, it will become the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination for uncontrolled asthma patients.


Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Enerzair Breezhaler

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 01, 2020

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10

Luxepack
Not Confirmed
Luxepack
Not Confirmed

Details : If the EC follows this recommendation and approves Enerzair® Breezhaler®, it will become the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination for uncontrolled asthma patients.

Brand Name : Enerzair Breezhaler

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 01, 2020

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NEWS #PharmaBuzz

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http://www.pharmabiz.com/NewsDetails.aspx?aid=142343&sid=2

PHARMABIZ
06 Sep 2021

http://www.pharmatimes.com/news/high-dose_enerzair_breezhaler_further_cuts_asthma_exacerbations_1348771

Selina McKee PHARMATIMES
07 Sep 2020

http://www.pharmabiz.com/NewsDetails.aspx?aid=130923&sid=2

PHARMABIZ
07 Sep 2020

https://www.novartis.com/news/media-releases/novartis-phase-iii-iridium-data-lancet-respiratory-medicine-show-benefit-enerzair-breezhaler-qvm149-first-class-inhaled-labalamaics-combination-uncontrolled

PRESS RELEASE
10 Jul 2020

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Annual Reports

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01

Brand Name : Ultibro Group

Indacaterol

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Luxepack
Not Confirmed

Brand Name : Ultibro Group

Switzerland
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Luxepack
Not Confirmed

Indacaterol

Main Therapeutic Indication : Respiratory Disorders

Currency : USD

2021 Revenue in Millions : 584

2020 Revenue in Millions : 623

Growth (%) : -6

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