Ways2Capital Reviews : Cadila Gets USFDA Nod For Triamterene And Hydrochlorothiazide Tablets

Cadila Healthcare has received final USFDA approval to market Triamterene and Hydrochlorothiazide tablets in strengths of 37.5mg/25mg and 75mg/50mg. This drug is used in the treatment of high blood pressure. This combination drug is used by patients who have a risk for having low potassium levels on hydrochlorothiazide.

As per Bloomberg, the US market for Triamterene and Hydrochlorothiazide Tablets is ~$100mn of which 98% of the market is with the generics companies. There are five generic companies with approval in both the strengths. In our opinion, this is likely to be $3-4mn opportunity for the company assuming 5% market share and 20% price erosion.

Cadila will manufacture this drug at it’s Ahmedabad-SEZ, manufacturing facility which was successfully inspected by USFDA from 28 May to 5 June, 2018.

Company currently has more than 195 ANDA approvals and has filed over 320 ANDAs. Company recently has received USFDA approvals for gTadalafil (tentitative), and final approval to Doxycycline Hyclate Capsules.

As per the Q4FY18 conference call, Zydus Cadiila is in ramp up stage in the US market. Company is expecting strong US revenue growth due to the ~50 product launches in the US over FY19E. This includes some limited competition product launches. Company expects strong launch momentum due to dedicated teams and de-bottlenecked facilities.
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About Bhoomi Desai