02 October 2007 17:51 [Source: ICIS news]
MILAN (ICIS news)--The United States Pharmacopeia (USP) has awarded a specific verification mark to two APIs (active pharmaceutical ingredients), ramipril and finasteride, manufactured by Hyderabad, India-based Dr Reddy’s Laboratories, the USP said on Tuesday at CPhI Worldwide 2007.
“The benefit of this to Dr Reddy’s is it has invited USP to review its work - this is a voluntary programme - and USP can attest to the quality of their manufacturing processes,” said Rich Wailes, USP vice-president of sales and marketing.
The USP pharmaceutical ingredient verification programme is important for several reasons. Many of the ingredients that go into the products that reach consumers seldom, if ever, receive inspections, even in advanced countries, Wailes said.
“Manufacturers of most drug products seek high quality drug substances to include their products. USP’s pharmaceutical ingredient verification programme provides an independent, science-based review of the quality process and assures purchasers that USP has put its name and reputation on the line,” said Wailes.
Dr Reddy’s is the first company in the world to receive USP verification for pharmaceutical ingredients. The company also has two other APIs in the final stages of verification by the USP.
The USP began its pharmaceutical ingredient verification programme a year ago. It also has verification programmes for dietary supplements and dietary supplement ingredients.
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