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Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Fosinopril Sodium and Hydrochlorothiazide tablets in 10 mg/12.5 mg and 20 mg/12.5 mg strengths, its US-based wholly subsidiary Ranbaxy Pharmaceuticals Inc announced on Thursday.
The medicine is indicated for the treatment of hypertension. These fixed dose combinations are not indicated for initial therapy.
"This tentative approval reflects our continued effort and commitment to supply affordable generic product formulations to the (US) market. This represents the 13th FDA approval to date and complements our approval earlier this year for Fosinopril tablets. This will allow us to offer both formulations to our customers," Jim Meehan, vice president (sales and Marketing) for RPI, said.
RPI is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.
RLL, India's largest pharmaceutical company, manufactures and markets branded and generic pharmaceuticals and active pharmaceutical ingredients.