Mfg News: Dr. Reddy’s, Vedanta Biosciences & Athenex
A roundup of manufacturing news from Dr. Reddy Laboratories, Vedanta Biosciences, and Athenex. Highlights below.
FDA Cites Dr. Reddy’s Formulation Plant
The US Food and Drug Administration (FDA) has issued two observations in a Form 483 after concluding a pre-approval inspection at Dr. Reddy’s Laboratories’ formulation manufacturing facility in Srikakulam, Andhra Pradesh, India.
The inspection was conducted from June 30, 2022 to July 7, 2022. The company says it will address the observations within FDA’s stipulated time frame.
Source: Dr. Reddy Laboratories
Vedanta Biosciences Opens Mfg Facility
Vedanta Biosciences, a Cambridge, Massachusetts-based bio/pharmaceutical company of oral drugs based on defined bacterial consortia, has opened a new cGMP clinical- and commercial-scale manufacturing facility to support its therapeutic portfolio, including a planned Phase III study and potential commercial launch of its lead candidate, VE303, a drug to treat Clostridioides difficile infection.
The company’s manufacturing process for bacterial consortia is based on the isolation and storage of individual strains of bacteria in clonal cell banks, their subsequent fermentation, lyophilization, blending into defined consortia, and filling into capsules for oral administration.
Source: Vedanta Biosciences
Athenex To Divest API Mfg Ops in China
Athenex, a Buffalo, New York-based clinical-stage bio/pharmaceutical company, has agreed to sell its equity interests in its China subsidiaries, which are primarily engaged in active pharmaceutical ingredient (API) manufacturing to TiHe Capital (Beijing) Co., Ltd. for RMB 124.4 million ($19.0 million). Athenex will receive at least 70% of the proceeds at closing, followed by 20% within three months after closing, and the remaining balance within six months after closing. The deal is subject to customary closing conditions, including obtaining certain regulatory approvals in China. Athenex and TiHe also plan to enter into a long-term supply agreement for the manufacture and supply of certain API products. Athenex’s clinical pipeline includes small molecules, biologics, and cell therapies for the treatment of cancer.