ROCKVILLE, Md. — The U.S. Pharmacopeia (USP) announced the opening of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia as part of its launch of a suite of R&D analytical solutions. These analytical lab services will support the efforts of drug manufacturers seeking to adopt advanced manufacturing technologies including pharmaceutical continuous manufacturing (PCM) as
ROCKVILLE, Md. — The U.S. Pharmacopeia (USP) has launched a new portfolio of impurities materials to support pharmaceutical manufacturers efforts to accelerate and strengthen analytical R&D and process development. USP Pharmaceutical Analytical Impurities (PAIs) support impurity analysis and profiling requirements during drug development and throughout the product lifecycle. Changes in the pharmaceutical industry, including new manufacturing
ROCKVILLE, Md. – Antibiotics are 42% more likely to be in shortage compared to all other drugs, according to the latest analysis from the U.S. Pharmacopeia’s (USP) Medicine Supply Vulnerability Insights Series. The findings are sourced from USP’s global Medicine Supply Map, derived from 40 external datasets and proprietary information about the use of USP quality standards, spanning
ROCKVILLE, Md. – USP has announced the release of six new Reference Standards to support manufacturers and regulators in analyzing and monitoring potentially harmful nitrosamine impurities in the drug supply chain. N-Nitrosodimethylamine (NDMA) (1 mg/mL in methanol) N-Nitrosodiethylamine (NDEA) (1 mg/mL in methanol) N-Nitrosodiisopropylamine (NDIPA) (1 mg/mL in methanol) N-Nitrosodibutylamine (NDBA) (1 mg/mL in methanol) N-Nitrosoethylisopropylamine (NEIPA)
SHIRLEY, N.Y. — American Regent announces the introduction and availability of estradiol valerate injection, USP – AO Rated and therapeutically equivalent to Delestrogen. Estradiol valerate injection is indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the
This year marks an important milestone for USP — and the entire health care sector. As we celebrate our 200th anniversary and gear up for our 2020 Convention, it’s an appropriate time to look at the work we’ve done and what lies ahead of us. From new technologies such as digital therapeutics, immunotherapy and artificial
PARSIPPANY, N.J. — Teva Pharmaceutical Industries announced the release of limited doses of the FDA-approved generic version of EpiPen (epinephrine injection, USP) Auto-Injector, 0.3 mg, in the U.S. Teva’s generic version of the EpiPen Jr (epinephrine injection, USP) Auto-Injector, 0.15 mg, and an additional supply of Teva’s generic version of the EpiPen (epinephrine injection, USP) Auto-Injector,
WASHINGTON — A coalition of pharmacy industry organizations has asked congressional leaders to weigh proposals that would free certain biologic drugs from adherence to U.S. Pharmacopeia (USP) standards. This week, the American Pharmacists Association (APhA) and eight other groups sent a letter to the chairman and ranking members of key House and Senate committees expressing
ROCKVILLE, Md. — The U.S. Pharmacopeial Convention (USP) is expanding its verification services to include a new Good Manufacturing Practice (GMP) audit program for dietary supplement and dietary ingredient manufacturers. USP said Monday that the program will help ensure that manufacturers have good quality systems and mitigate regulatory risks by readying manufacturers for Food and
