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Respiratory

Asthma and COPD together affect around half a billion people and cause close to 4 million deaths a year, with 90% of the premature deaths occurring in low- and middle-income countries. Steroid inhalers, central to long-term asthma control, are available in only 40% of countries.

171 Molecules in range

47 of these 171 lines are pressurised metered-dose inhalers and 30 are nasal sprays, both requiring fill capability separate from standard oral and sterile lines.

Range depth

ICS and LABA inhalers

23 formoterol and 16 fluticasone presentations.

  • Salmeterol 25mcg & Fluticasone 125mcg Inhaler
  • Budesonide & Formoterol (5 strengths)
  • Beclomethasone 100mcg & Formoterol 6mcg Inhaler

Long-acting bronchodilators

6 tiotropium presentations.

  • Tiotropium 18mcg Powder Inhaler
  • Tiotropium & Formoterol MDI
  • Mometasone 100mcg & Formoterol 6mcg Inhaler

Nasal sprays

30 aqueous nasal presentations.

  • Mometasone Furoate Nasal Spray
  • Fluticasone Nasal Spray

Oral respiratory

24 montelukast presentations.

  • Levocetirizine & Ambroxol & Montelukast Syrup
  • Montelukast 10mg
  • Dextromethorphan & Guaifenesin & Bromhexine & Chlorpheniramine
Dosage forms
47Tablet
47Inhaler / MDI
40Liquid / Syrup
30Nasal Spray
6Injectable
1Capsule

Which molecules are worth filing depends on your market, and on what you already stock.

01

Market and competitor analysis

We establish what is already registered in your market, who supplies it today, and where demand is going unmet.

02

Range cross-match

We set your current range against the portfolio and separate genuine gaps from lines you already stock.

03

Ranked shortlist

You get the molecules in filing order, which of them need a dossier built for your authority, and which fall outside the range.

04

Documentation

We compile the dossier in CTD format for your authority and supply the COPP and plant-level WHO-GMP and PIC/S certificates behind it.

A gap analysis starts with your market and your current range.

We analyse your market and set your existing range against the portfolio, then return the molecules worth filing in priority order with the documentation route for each.

We review every enquiry and respond where there is a portfolio fit.