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 µg |
Manufactured |
|
|
Belcometasone dipropionate |
Beklam 100 µg |
Manufactured |
|
|
Belcometasone dipropionate |
Beklam 200 µg |
Manufactured |
|
|
Belcometasone dipropionate |
Beclometasone Inhaler 50
µg |
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 µg |
Manufactured |
|
|
Budesonide |
Budvent 100 µg |
Manufactured |
|
|
Budesonide |
Budez 200 µg |
Manufactured |
|
|
Budesonide |
Budvent Forte 200 µg |
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 |