CANAGLIFLOZIN HEMIHYDRATE

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An overview

SODIUM-GLUCOSE COTRANSPORTER 2 (SGLT2) INHIBITOR
Treatment of adults with insufficiently controlled type 2 diabetes mellitus to lower blood sugar levels, reduce the risk of stroke, heart attack or death and decrease the risk of end-stage kidney failure, worsening kidney function, need for hospitalization for heart failure and cardiovascular death.

Description / use

Product type: antidiabetic.
CAS number: 928672-86-0.
Common indications: type 2 diabetes mellitus.
Product status: development.
Available grades: current PSD: D10 < 5µm; D50 < 10µm; D90 < 50µm.

PROPERTIES

Oral administration.
Rapid absorption (1-2h).
Potential global treatment candidates about 150 million people.
CAGR (2023-2033) over +2.7%.

Advantages

Efficacy:

Polymorphic Form I (EMA/374133/2013) confirmed.
GMP Production capabilities up to 2.500 kg/year.
3 weeks per batch production and release.
Indian manufacturer freedom to operate for this product.
Development samples and standards available with CoA.
Two impurities identified. Total impurities around 0.1%.
Purity > 98%.

Safety:

Analytical and process validations following international guidelines.
No monograph. In compliance with general regulatory requirements.
Stable room temperature
Industrial quantities available in Q3 2025.
Strong commercial team globally distributed.
Competitive price based on market.

Polymorphic Form I (EMA/374133/2013) confirmed.
GMP Production capabilities up to 2.500 kg/year.
3 weeks per batch production and release.
Indian manufacturer freedom to operate for this product.
Development samples and standards available with CoA.
Two impurities identified. Total impurities around 0.1%.
Purity > 98%.
Analytical and process validations following international guidelines.
No monograph. In compliance with general regulatory requirements.
Stable room temperature.
Industrial quantities available in Q3 2025.
Strong commercial team globally distributed.
Competitive price based on market.

Final product innovator presentations

Monotherapy: Canagliflozin hemihydrate 100 mg; 300 mg.
Combined: Canagliflozin hemihydrate / Metformin hydrochloride 50 mg/850 mg; 50 mg/1.000 mg; 150 mg/850 mg; 150 mg/1.000 mg.

Functional benefits

Can be applied in patients with cardiac and vascular disease and severe renal insufficiency.
Similar efficacy than other products of the same family.
Higher security due to less hypoglycemia risk than other products for same therapeutic line.