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Hormonal, Nephrology & Specialty

Combined category

788 million adults were estimated to have chronic kidney disease in 2023, up from 378 million in 1990, making it the ninth leading cause of death globally. Access to kidney replacement therapy varies by a factor of 200 between high-income regions and low-income countries.

135 Molecules in range

Transplant immunosuppressants, oncology orals and nephrology binders sit inside one range of 135, with 32 injectable presentations.

Range depth

Transplant immunosuppressants

Tacrolimus from 0.25mg.

  • Tacrolimus Capsule USP 0.25 – 2mg
  • Mycophenolate 500mg Tablet

Oncology orals

Hormone-receptor and antiandrogen lines.

  • Anastrozole 1mg
  • Letrozole 2.5mg
  • Tamoxifen 10 / 20mg

Nephrology

Phosphate binder and calcimimetic lines.

  • Sevelamer Carbonate 400 / 800mg
  • Cinacalcet Tablet 30mg

Urology and reproductive health

7 tamsulosin and dutasteride presentations.

  • Dutasteride & Tamsulosin Capsule IP
  • Medroxyprogesterone Acetate 150mg/ml
  • Testosterone Mixed Esters 250mg/ml
Dosage forms
85Tablet
32Injectable
17Capsule
1Sachet / Powder

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.