Annexure

 

SUMMARY OF DATA ON METERED DOSE INHALER (MDI) AND DRY POWER INHALER (DPI) IN INDIA

 

I. CFC MDIs : Produced for export

Name of the

Active Ingredient

Brand Name

Source

Aerocort INH

Salbutamol + Beclomethasone Dipropionate

Manufactured/Imported

 

Asthalin INH

Salbutamol

Manufactured

Beclate-50 INH

Beclomethasone Dipropionate`

Manufactured/Imported

Beclate-100 INH

Beclomethasone Diproprionate

Manufactured/Imported

Beclate-200 INH

Beclomethasone Diproprionate

Manufactured/Imported

Beclate-250 INH

Beclomethasone Diproprionate

Manufactured/Imported

Beclomethsaone

Dipropionate

Besone,50,250

 

Manufactured

 

Cromal INH

Sodium Chromoglyclate

Imported

Duolin Inhaler

Salbutamol Sulphate +

Ipratropium Bromide

Manufactured

Imported

Flohale 25 INH

Fluticasone Propionate

Manufactured

Flohale 50 INH

Fluticasone Propionate

Manufactured

Flohale 125 INH

Fluticasone Propionate

Manufactured

Foratec INH

Formeterol Fumerate

Manufactured

Ipravent 20 INH

Ipratropium Bromide

Imported

Ipravent Forte INH

Ipratropium Bromide

Imported

Salbutamol

Salbutamol Inhaler

IDA-The Netherland

Salbutamol

Butahale

Manufactured

Salbutamol

Bonair

Manufacture

Salmeterol Xenofoate

 

Salmeter 120

Manufactured

Serobid 200MD INH

Salmeterol Xinafoate

Manufactured

Seroflo 50 INH

Salmeterol + Fluticasone Propionate

Manufacture

Seroflo 125 INH

Salmeterol + Fluticasone Propionate

Manufactured

Seroflo 250 INH

Salmeterol + Fluticasone Propionate

Manufactured

 

 

 

 

 

 

 

 

 

 

CFC MDIs : Sold and distributed in India

 

Name of the

Active Ingredient

Brand Name

Source

Aerocort INH

Salbutamol + Beclomethasone Dipropionate

Manufactured

 

Asthalin INH

Salbutamol

Manufactured/Imported

 

Beclate-50 INH

Beclomethasone Dipropionate`

Manufactured/Imported

 

Beclate-100 INH

Beclomethasone Diproprionate

Manufactured/Imported

 

Beclate-200 INH

Beclomethasone Diproprionate

Manufactured/Imported

 

Beclate-250 INH

Beclomethasone Diproprionate

Manufactured/Imported

 

Belcometasone dipropionate

Beklam 50 g

Manufactured

 

Belcometasone dipropionate

Beklam 100 g

Manufactured

 

Belcometasone dipropionate

Beklam 200 g

Manufactured

 

Belcometasone dipropionate

Beclometasone Inhaler 50 g

Manufactured

 

Beclomethasone Dipropionate

Becoride Inhaler 100 mcg

Manufactured

 

Beclomethasone Dipropionate

Becoride Forte Inhaler 250 mcg

Manufactured

 

Beclomethasone Dipropionate

Besone, Bevent, Bevent Forte, Beclowil, Asticort 50/100/200/250

Manufactured

 

Budesonide

Budez 100 g

Manufactured

 

Budesonide

Budvent 100 g

Manufactured

 

Budesonide

Budez 200 g

Manufactured

 

Budesonide

Budvent Forte 200 g

Manufactured

 

Budesonide

Budesone 200/100

Budvent, Budvent Forte, Derinide

 

Manufactured

 

Budesonide

Budez 100

Budez 200

Manufactured

 

Budesonide

Pulmicort / Rhinocort

 

Imported

 

 

Budesonide & Formoterol Fumarate

Formonide 100/200/400

Manufactured

 

Cromal INH

Sodium Chromoglyclate

Imported

 

Duolin Inhaler

Salbutamol Sulphate +

Ipratropium Bromide

Manufactured

 

 

 

 

 

 

 

 

 

 

Name of the

Active Ingredient

Brand Name

Source

Flohale 25 INH

Fluticasone Propionate

Manufactured

 

Flohale 50 INH

Fluticasone Propionate

Manufactured

 

Flohale 125 INH

Fluticasone Propionate

Manufactured

 

Fluticasone Propionate

Floease 50

Floease 125

Manufactured

 

Fluticasone Priopionate &

Salmetrol Hydroxy

Napthoate

Combitide 50,

Combitide 125

Combitide 250

Manufactured

 

Fluticasone Priopionate

Floease 125

Manufactured

 

Fluticasone Priopionate

Floease 50

Manufactured

 

Formoterol Fumarate

Deriform

Manufactured

 

Foratec INH

Formeterol Fumerate

Manufactured

 

Salbutanol

Ventorlin Inhaler

Manufactured

 

Salbutamol

Aerotaz

Manufactured

 

Salbutamol

Bronkonat

Manufactured

 

Salbutamol

Bronkonat

Manufactured

 

Salbutamol

Vent

 

Salbutamol

Bonair, Salvent, Astinol, Aerobon,Durasal, Derihaler, Vent

Manufactured

 

 

Salbutamol & Ipratropium

Combimist, Ventipra, Duovent

Manufactured

 

Salbutamol & Beclomethasone

Salbesone,Vent Plus, Durabec, Asticort SA

Manufactured

 

Salmeterol Xinafoate

Salmair, Salvent, Fluvent, Fluvent Forte

Manufactured

 

Salmeterol Xinafoate

Salmeter 200

Manufactured

 

Salmeterol Xinafoate

Arzol

Manufactured

 

Salmeterol Xinafoate

Salvent

Imported

 

Salmetrol

Arzol

Manufactured

 

Salmeterol & Fluticasone Propionate

Vent SF 125

Manufactured

 

Serobid 200MD INH

Salmeterol Xinafoate

Manufactured

 

Seroflo 50 INH

Salmeterol + Fluticasone Propionate

Manufactured

 

Seroflo 125 INH

Salmeterol + Fluticasone Propionate

Manufactured

 

Seroflo 250 INH

Salmeterol + Fluticasone Propionate

Manufactured

 

Sodium Cromoglycate

S-Cromair, Fintal

Manufactured

 

Terbutaline Sulphate

Bricanyl Inhaler

Manufactured

 

 

 

 

 

 

 

 

 

 

II. DPIs : Produced for export

Name of the

Active Ingredient

Brand Name

Source :

 

Aerocort R/C

 

Salbutamol +

Beclomethasone Dipropionate

Manufactured

Aerocort Forte R/C

Salbutamol +

Beclomethasone Dipropionate

Manufacture

Beclate 100 R/C

Beclomethasone Dipropionate

Manufactured

Beclate 200 R/C

Beclomethasone Dipropionate

Manufactured

Beclate 400 R/C

Beclomethasone Dipropionate

Manufacture

Budecort 100 R/C

Budesonide

Manufactured

Budecort 200 R/C

Budesonide

Manufactured

Budecort 400 R/C

Budesonide

Manufactured

Cromol R/C

Sodium Chromoglyclate

Manufactured

Duolin R/C

Salbutamol Sulphate +

Ipratropium Bromide

Manufactured

Foratec R/C

Formeterol Fumerate

Manufactured

Foracort 100R/C

 

Formeterol Fumerate + Budesonide

Manufctured

Foracort 200 R/C

Formeterol Fumerate + Budesonide

Manufactured

Foracort 400 R/C

Formeterol Fumerate + Budesonide

Manufactured

Flohale 50 R/C

Fluticasone Propionate

Manufacture

Flohale 100 R/C

Fluticasone Propionate

Manufactured

Flohale 200 R/C

Fluticasone Propionate

Manufactured

Ipravent R/C

Ipratropium Bromide

Imported

Serobid R/C

Salmeterol Xinafoate

Manufactured

Seroflo 100 R/C

Salmeterol Xinafoate

Manufactured

Seroflo 250 R/C

Salmeterol + Fluticasone

Manufacture

Seroflo 500 R/C

Salmeterol + Fluticasone

Manufactured

DPIs : Sold and distributed in India

 

Aerocort R/C

Salbutamol +

Beclomethasone Diapropionate

Manufactured

Aerocort Forte R/C

Salbutamol +

Beclomethasone Diapropionate

Manufactured

Beclate 100 R/C

Beclomethasone Dipropionate

Manufactured

Beclate 200 R/C

Beclomethasone Dipropionate

Manufactured

Beclate 400 R/C

Beclomethasone Dipropionate

Manufactured

Budecort 100 R/C

Budesonide

Manufactured

Budecort 200 R/C

Budesonide

Manufactured

Budecort 400 R/C

Budesonide

Manufactured

Cromol R/C

Sodium Chromoglyclate

Imported

 

 

 

 

 

 

 

 

Name of the

Active Ingredient

Brand Name

Source :

 

Duolin R/C

Salbutamol Sulphate +

Ipratropium Bromide

Manufactured

Flohale 50 R/C

Fluticasone Propionate

Manufactured

Flohale 100 R/C

Fluticasone Propionate

Manufactured

Flohale 200 R/C

Fluticasone Propionate

Manufactured

Foracort 100R/C

Formeterol Fumerate + Budesonide

Manufactured

Foracort 200 R/C

Formeterol Fumerate + Budesonide

Manufactured

Foracort 400 R/C

Formeterol Fumerate + Budesonide

Manufactured

Foratec R/C

Formeterol Fumerate

Manufactured

Fluticasone Propionate +

Salmeterol

Seretide

Accuhaler

Imported

Ipravent R/C

Ipratropium Bromide

Imported

Serobid R/C

Salmeterol Xinafoate

Manufactured

Seroflo 100 R/C

Salmeterol Xinafoate

Manufactured

Seroflo 250 R/C

Salmeterol + Fluticasone

Manufactured

Seroflo 500 R/C

Salmeterol + Fluticasone

Manufactured

Tiova R/C

Tiopropium Bromide

Manufactured

III. NON CFC MDIs : Produced for export

Name of the

Active Ingredient

Brand Name

Source :

 

Asthavent Echaler

Salbutamol Sulphate

Manufactured

Beclate 100 INH

Beclomethasone Dipropionate

Manufacture

Beclate 250 INH

Beclomethasone Dipropionate

Manufactured

Budeflam 100 INH

Budesonide

Manufactured

Budeflam 200 INH

Budesonide

Manufacture

Foracort 100 INH

Formeterol Fumerate + Budesonide

Manufactured

Foracort 200 INH

Formeterol Fumerate + Budesonide

Manufacture

Foracort 400 INH

Formeterol Fumerate + Budesonide

Manufactured

NON CFC MDIs : Sold and distributed in India

Name of the

Active Ingredient

Brand Name

Source :

 

Budecort 100 INH

Budesonide

Manufactured

Budecort 200 INH

Budesonide

Manufactured

Foracort 100 INH

Formeterol Fumerate + Budesonide

Manufactured

Foracort 200 INH

Formeterol Fumerate + Budesonide

Manufactured

Foracort 400 INH

Formeterol Fumerate + Budesonide

Manufactured

Fluticasone Propionate

+ Salmeterol Xinafoate

 

Seretide Evohaler

Imported

 

 


Date of Approval by Health Authorities and launching of Product

 

NON CFC MDIs:

 

Brand Name

Date of approval

Date of authorisation

for marketing or

product launching

Budecort 100 INH

Mar-2002

Apr-2002

Budecort 200 INH

Mar-2002

Apr-2002

Foracort 100 INH

Nov-2002

Dec-2002

Foracort 200 INH

Nov-2002

Dec-2002

Foracort 400 INH

Nov-2002

Jun-2003

Asthavent Inhaler

Jun-1999

Aug-1999

(i)                  Besone 50

(ii)                Besone 250

(iii)               Asthain

04.12.2000

04.12.2000

22.07.2003

04.12.2000

04.12.2000

22.07.2003

Salmeter HFA - from DCA

03-02-2003

Yet to be received

DPIs

Aerocort R/C

May-1992

Dec-1992

Aerocort Forte R/C

May-1992

Feb-1999

Beclate 100 R/C

Mar-1990

Mar-1990

Beclate 200 R/C

Mar-1990

Mar-1990

Beclate 400 R/C

Jan-1994

Mar-1998

Budecort 100 R/C

Apr-1995

Oct-1996

Budecort 200 R/C

Apr-1995

Oct-1996

Budecort 400 R/C

Apr-1995

Jun-1998

Cromol R/C

Mar-1995

Apr-1998

Duolin R/C

Mar-2000

Sep-2000

Foratec R/C

Mar-2000

Jun-2000

Foracort 100R/C

Aug-2001

Oct-2001

Foracort 200 R/C

Aug-2001

Oct-2001

Foracort 400 R/C

Mar-2002

Aug-2002

Flohale 50 R/C

Nov-1997

Feb-1999

Flohale 100 R/C

Nov-1997

May-1998

Flohale 200 R/C

Nov-1997

May-1998

Ipravent R/C

Mar-2000

Dec-2000

Serobid R/C

Dec-1993

Feb-1994

Seroflo 100 R/C

Jun-2000

Dec-2000

Seroflo 250 R/C

Jun-2000

Dec-2000

Seroflo 500 R/C

Jun-2000

Dec-2000

Tiova R/C

Apr-2003

Apr-2003