Two drug substances manufactured by Dr. Reddy's Laboratories Ltd, Hyderabad, have been awarded a special verification mark by the United States Pharmacopeial Convention (USP) indicating rigorous independent testing.
Dr. Reddy's may now use this special mark for two active pharmaceutical ingredients - Ramipril and Finasteride - on its certificate of analyses and other materials conform with USP's Pharmaceutical Ingredient Verification Programme (PIVP).
AdvertisementDr. Reddy's was the first manufacturer to enter the USP PIVP. Two more drug substances manufactured by Dr. Reddy's are in the final stages of verification by USP, the non-profit, non-governmental, standards-setting organisation said.
"USP believes these programmes are critically needed in a world with many thousands of manufacturers making many thousands of pharmaceutical ingredients," said Roger L. Williams, USP's executive vice president and CEO.
Many of these ingredients seldom receive inspections, even in advanced countries, and many may be substandard or even counterfeit, he noted.
However, the PIVP mark is not intended to signal a well-manufactured drug product, which is the responsibility of a dosage form manufacturer working with a responsible regulatory agency, he said.
Satish Reddy, COO and managing director of Dr. Reddy's Laboratories, stated: "This certification from a highly respectable body such as the USP is yet another veracious witness of quality systems that are internalised in the operations at Dr. Reddy's. We will continue to work closely with USP to expand the coverage of this certification programme in Dr. Reddy's."