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ACTIVE PHARMA INGREDIENTS

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NDC API

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NDC API

API REF. PRICE (USD/KG)

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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 SUPPLIERS

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01

Inke S.A

Spain

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInke S.A: APIs manufacturing plant.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Inke Company Banner

02

Deccan Nutraceuticals Pvt. Ltd

India

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

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Medlab Asia & Asia Health
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDeccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Deccan Nutraceuticals

03

Vamsi Labs

India

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

  • fda
  • EDQM
  • WHO-GMP

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

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Vamsi Labs

04

Neuland Laboratories

India

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

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Medlab Asia & Asia Health
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Neuland

05

Breathgreen Pharmaceuticals

U.S.A

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

Medlab Asia & Asia Health
Not Confirmed
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Breathgreen Pharmaceuticals

U.S.A

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

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Medlab Asia & Asia Health
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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06

Cipla

India

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

Medlab Asia & Asia Health
Not Confirmed
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Cipla

India

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

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Medlab Asia & Asia Health
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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07

Beijing Breathgreen Healthcare

China

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

Medlab Asia & Asia Health
Not Confirmed
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Beijing Breathgreen Healthcare

China

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

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Medlab Asia & Asia Health
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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AES 2024
Not Confirmed

02

Cipla Ltd

India

USDMF

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AES 2024
Not Confirmed

02

Cipla Ltd

India
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AES 2024
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37098

Submission : 2022-05-13

Status : Active

Type : II

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Listed Suppliers

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01

Inke S.A

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInke S.A: APIs manufacturing plant.

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Indacaterol Acetate

About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...

Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.
Inke Company Banner

02

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Medlab Asia & Asia Health
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDeccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.

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Digital Content Digital Content

Indacaterol Acetate

About the Company : Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their co...

Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their commitment to quality and adherence to Current Good Manufacturing Practices (CGMP) are integral to their operations. The company has been successfully audited by USFDA (5 times) and EDQM (2 times). The company manufactures high quality phytochemicals, semi-synthetic and synthetic APIs. DNPL stands as a responsible pharmaceutical manufacturer, devoted to delivering premium products across all the regions we serve.
Deccan Nutraceuticals

03

Vamsi Labs

India
  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content

Indacaterol Acetate

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 domestic & international ma...

Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domestic & international markets(50% sales). Anti-asthma products account for 60% of sales. Vamsi adheres to high corporate governance, transparency, professionalism, & environmental protection standards. It's USFDA & EDQM certified & ISO 9001:2015, ISO 14001:2015, & ISO 45001:2018 certified. With a DSIR-certified R&D Lab, Vamsi continues to innovate & meet the pharma industry's evolving needs. Vamsi is poised to grow its globally while maintaining commitment to excellence and sustainability.
Vamsi Labs

04

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Medlab Asia & Asia Health
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Indacaterol Acetate

About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...

Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.
Neuland

05

Medlab Asia & Asia Health
Not Confirmed
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Indacaterol Acetate

About the Company : Beijing Breathgreen Healthcare Co. Ltd was established in 2008. The company has extensive experience in developing high-quality API products for inhalation formulation and providin...

Beijing Breathgreen Healthcare Co. Ltd was established in 2008. The company has extensive experience in developing high-quality API products for inhalation formulation and providing customized special powder processing technology services to both domestic and foreign customers. Their range of products includes sterile and non-sterile glucocorticoids, B2 receptor agonists, and M receptor antagonists. Breathgreen has a strong quality management system, production system, and EHS management system that complies with cGMP standards.
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API Reference Price

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28-Jul-2021
27-Aug-2024
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