Mfg News: AstraZeneca, Stada and Lupin
A roundup of manufacturing news from Stada, AstraZeneca, National Resilience and Lupin. Highlights below.
Stada Breaks Ground on $52-M Solid-Dose Packaging Facility
Stada, a Bad Vilbel, Germany-based specialty pharma, generics, and non-prescription consumer healthcare company, has broken ground on a EUR 50 million ($52 million), 100,000-square meter solid-dose packaging facility in Romania.
The supply-chain and packaging unit located in Turda, Romania, will initially house nine lines for solid-dose medicines such as tablets and capsules, with a capacity to supply 100 million packs per year. It will also have an automated warehouse with capacity for 7,400 pallets.
Stada expects to commence operations at the facility by the end of 2024, following the receipt of all necessary GMP and other certifications.
AstraZeneca Agrees To Sell Drug-Product Mfg Site to National Resilience
AstraZeneca has agreed to sell its drug-product manufacturing site in West Chester, Ohio, to National Resilience, a San Diego, California-based CDMO of biologics and advanced therapies.
The West Chester site is a commercial-scale, 580,000-square-foot facility equipped with end-to-end drug product manufacturing capabilities, including aseptic filling, inspection, packaging, labeling, and cold-chain operations for vials, cartridges, pre-filled syringes, and autoinjectors, as well as a virtual reality training center. Resilience will acquire the West Chester site’s operations and physical assets, retain the site’s leadership and employees, and continue to invest in the workforce and facility.
In addition to acquiring the facility, Resilience will manufacture select AstraZeneca medicines at the facility as part of a multi-year supply agreement.
The companies anticipate completing the transaction in early 2023, subject to receipt of regulatory approvals and the satisfaction of other customary closing conditions.
FDA Cites Lupin’s API and Drug-Product Mfg Site
The US Food and Drug Administration has issued Lupin, a Mumbai, India-headquartered bio/pharmaceutical company, a Form 483 with eight observations each for the company’s active pharmaceutical ingredient (API) manufacturing facility and drug-product manufacturing facility, both located at the company’s site in Mandideep, Madhya Pradesh, India, following an inspection at the site. The inspection took place November 14, 2022 to November 23, 2022.
“We are committed to addressing the observations and will work with the US FDA to resolve these issues at the earliest,” said the company in a November 24, 2022, notification letter to the Bombay Stock Exchange and the National Stock Exchange of India.
This is the latest of recent manufacturing issues for the company. In late September (September 2022), the FDA issued Lupin a Warning Letter for its API manufacturing facility in Boisar, Palghar, Maharashtra, India. Additionally, in late October (October 2022) the FDA issued Lupin a Form 483 for its biomanufacturing facility in Pune, India. Most recently, in November (November 2022), the FDA issued Lupin a Form 483 for its injectables manufacturing facility in Nagpur, Maharashtra, India.