Manufacturers

“There's a lot of third-party audit information out there. Could we take that and apply it into our inspectional planning process?” says Office of Dietary Supplement Programs Director Cara Welch.

Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.

A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.

Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.

In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.

In announcement of approving VKT Pharma’s application, FDA included storage and handling instructions common in labeling, suggesting concerns persist about the potential for NDMA to form after products are distributed.

Lawmakers in IL, MA and NJ as well as MI consider proposals as firms marketing weight loss and bodybuilding supplements in New York already are subject to first-ever state law limiting sales of products to consumers 18 and older.

OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.

Three-judge Second Circuit panel rejects CRN’s argument that New York General Business Law Section 391-oo, effective since April 2024 as first in US to prohibit sales of certain supplements to consumers under 18, violates First Amendment rights of supplement marketers.

Supply-chain bottlenecks, heavy wholesaler de-stocking, and tighter working-capital controls sent Gedeon Richter’s General Medicines sales down by 17% and slashed adjusted EBIT by nearly two-thirds in Q3.

Dave Wendland retires after 34 years at HRG; AHPA science chief Holly Johnson earns WIN Guiding Star; Strategy, people leads for Vitamin Shoppe; CDMO Kenox appoints R&D, manufacturing VP; and contract manufacturer Radienz adds customer chief.

Kenvue share price on downward trend since its highly anticipated spinout from J&J in 2023.