European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
01 1Polpharma
02 84Novartis Pharmaceuticals Corporation
03 7Novartis South Africa (Pty) Ltd
01 1CAPSULE
02 7CPS
03 31Capsule For Inhalation
04 6Inhalation Powder (Hard Capsule)
05 17Inhalation Powder Hard Capsule
06 2POWDER;INHALATION
07 12Powder For Inhalation Hard Capsule
08 16Blank
01 7Allowed
02 10Approved
03 18Authorized
04 2DISCN
05 4Marketed
06 1Not Marketed
07 7Originator
08 27Prescription
09 16Blank
01 1ARCAPTA NEOHALER
02 9Atectura Breezhaler
03 3Atectura Breezhaler ?g
04 3Bemrist Breezhaler
05 1Bemrist Breezhaler 150/160
06 1Bemrist Breezhaler 150/320
07 1Bemrist Breezhaler 150/80
08 5Enerzair Breezhaler
09 1Enerzair Breezhaler ?g
10 6Hirobriz Breezhaler
11 1Indacaterol/Glycopyrronium Polpharma
12 4Onbrez
13 21Onbrez Breezhaler
14 1Onbrez Breezhaler 150Ug
15 8Oslif Breezhaler
16 1ULTIBRO BREEZHALER
17 1UTIBRON NEOHALER
18 11Ultibro Breezhaler
19 2Ulunar Breezhaler
20 6Xoterna Breezhaler
21 1Zimbus Breezhaler
22 1Zimbus Breezhaler 150/50/160
23 1Zimbus Breezhaler 150/50/80
24 2ultibro breezhaler 110/50
01 16Australia
02 1Canada
03 9Denmark
04 17Estonia
05 5Norway
06 7South Africa
07 18Spain
08 10Sweden
09 7Switzerland
10 2USA
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Indacaterol/Glycopyrronium Polpharma
Dosage Form : Capsule For Inhalation
Dosage Strength : 85mcg; 43mcg
Packaging :
Approval Date : 15-09-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : DISCN
Registration Country : USA
Brand Name : ARCAPTA NEOHALER
Dosage Form : POWDER;INHALATION
Dosage Strength : EQ 75MCG BASE
Packaging :
Approval Date : 2011-07-01
Application Number : 22383
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
GLYCOPYRROLATE; INDACATEROL MALEATE
Brand Name : UTIBRON NEOHALER
Dosage Form : POWDER;INHALATION
Dosage Strength : 15.6MCG/INH;27.5MCG/INH
Packaging :
Approval Date : 2015-10-29
Application Number : 207930
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Ultibro Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 110mcg;50mcg
Packaging :
Approval Date : 10/07/2014
Application Number : 63132
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Indacaterol; Glycopyrronium; Mometasone Furose
Brand Name : Enerzair Breezhaler ?g
Dosage Form : Capsule For Inhalation
Dosage Strength : 150mcg;50mcg;160mcg
Packaging :
Approval Date : 24/09/2020
Application Number : 67596
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Indacaterol; Mometasone Furoate
Brand Name : Atectura Breezhaler ?g
Dosage Form : Capsule For Inhalation
Dosage Strength : 150mcg;80mcg
Packaging :
Approval Date : 10/09/2020
Application Number : 67597
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Indacaterol; Mometasone Furoate
Brand Name : Atectura Breezhaler ?g
Dosage Form : Capsule For Inhalation
Dosage Strength : 150mcg;160mcg
Packaging :
Approval Date : 10/09/2020
Application Number : 67597
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Indacaterol; Mometasone Furoate
Brand Name : Atectura Breezhaler ?g
Dosage Form : Capsule For Inhalation
Dosage Strength : 150mcg;320mcg
Packaging :
Approval Date : 10/09/2020
Application Number : 67597
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Onbrez Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 150mcg
Packaging :
Approval Date : 21/05/2010
Application Number : 60141
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Onbrez Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 300mcg
Packaging :
Approval Date : 21/05/2010
Application Number : 60141
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Onbrez Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 150mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Not Marketed
Registration Country : Norway
Brand Name : Onbrez Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 150mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Not Marketed
Registration Country : Norway
Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Onbrez Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 300mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Marketed
Registration Country : Norway
Indacaterol Maleate; Glycopyrronium bromide
Brand Name : Ultibro Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 85mcg; 43mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Marketed
Registration Country : Norway
Indacaterol Maleate; Glycopyrronium bromide
Brand Name : Ultibro Breezhaler
Dosage Form : Capsule For Inhalation
Dosage Strength : 85mcg; 43mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
Regulatory Info : Prescription
Registration Country : Estonia
Indacaterol; Glycopyrronium; Mometasone
Brand Name : Enerzair Breezhaler
Dosage Form : Inhalation Powder Hard Capsule
Dosage Strength : 114mcg; 46mcg; 136mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Prescription
Registration Country : Estonia
Indacaterol; Glycopyrronium; Mometasone
Brand Name : Zimbus Breezhaler
Dosage Form : Inhalation Powder Hard Capsule
Dosage Strength : 114mcg/dose; 46mcg/dose
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Prescription
Registration Country : Estonia
Indacaterol; Mometasone Furoate
Brand Name : Atectura Breezhaler
Dosage Form : Inhalation Powder Hard Capsule
Dosage Strength : 125mcg; 1275mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Prescription
Registration Country : Estonia
Indacaterol; Mometasone Furoate
Brand Name : Bemrist Breezhaler
Dosage Form : Inhalation Powder Hard Capsule
Dosage Strength : 125mcg; 1275mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
Regulatory Info : Prescription
Registration Country : Estonia
Indacaterol; Mometasone Furoate
Brand Name : Atectura Breezhaler
Dosage Form : Inhalation Powder Hard Capsule
Dosage Strength : 125mcg; 260mcg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia
