SATISFYER_1170x120_8-13-20

USP

USP launches new standards

USP launches new standards

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)

American Regent introduces estradiol valerate injection

American Regent introduces estradiol valerate injection

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

Teva’s generic epinephrine injection now available in limited quantity in the U.S.

Teva’s generic epinephrine injection now available in limited quantity in the U.S.

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,

Pharmacy groups advocate USP standards for biologics

Pharmacy groups advocate USP standards for biologics

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

USP rolls out GMP audit program for dietary supplements

USP rolls out GMP audit program for dietary supplements

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