Mumbai:Drug maker Glenmark Pharmaceuticals on Friday said its US based subsidiary, has got the Abbreviated New Drug Application (ANDA) approval from the US food and drug administration for Fosinopril Sodium and Hydrochlorothiazide tablet, used for the treatment of hypertension.
Glenmark Generics Inc, a subsidiary of the company has received ANDA approval through a partnership with another US based company, Invagen Pharmaceuticals Inc, Glenmark Pharmaceuticals said in a filing to the Bombay Stock Exchange.
“We are very pleased with this approval as it gives us the chance to provide customers with guaranteed and uninterrupted supply which they may not have been getting in the past. We anticipate a successful launch considering the limited competitive landscape coupled with the niche positioning of this product.” Glenmark Generics Ltd chief executive officer Terrance Coughlin said.
Fosinopril Sodium and Hydrochlorothiazide(HCTZ) tablets are available in both 10mg/12.5mg and 20mg/12.5mg strengths and are indicated for the treatment of hypertension, the filing said.
The company would exclusively market and distribute the product while InvaGen would be responsible for their manufacture and supply. All development, regulatory costs and profits on Fosinopril Sodium and Hydrochlorothiazide tablets’ sale in the US would be shared equally between Glenmark and Invagen, it added.
The ANDA approval for Fosinopril Sodium and Hydrochlorothiazide tablets was obtained through Glenmark’s longstanding partnership with InvaGen Pharmaceuticals Inc (InvaGen), the filing added.
In the fiscal year 2006, Glenmark and InvaGen entered into a collaborative agreement for the joint development, filing and marketing of several generic pharmaceutical products for the US market, it said.