Supplier News: Catalent, Euroapi, Croda & More
The latest from CDMOs, CMOs, and suppliers featuring Catalent, Euroapi, Croda, Charles River Laboratories, and C2 Pharma.
General
* Catalent Reports FY 3rd Quarterly Loss Due to Operational Issues at Three Facilities
Chemicals/Chemical API Manufacturing
* Euroapi Increasing Mfg Capacity of Controlled Substances
* C2 Pharma Gains OK for DMF of Digoxin in China
Biologics Manufacturing
* Charles River Launches Off-the-Shelf Lentiviral Vector Plasmids
Formulation Development/Drug Product Manufacturing
* Croda Breaks Ground on Excipient Mfg Facility
General
Catalent Reports FY 3rd Quarterly Loss Due to Operational Issues at Three Facilities
Catalent reported a $227-million loss in its fiscal year (FY) third quarter (ending March 31, 2023) on net revenue of $1.04 billion, a 19% decline (excluding the effect of acquisitions, divestitures, and currency translation) compared to the year-ago period. The net loss includes a goodwill impairment of $210 million, which includes the effect of a $42-million deferred-tax adjustment. Net income declined from $700 million in the third quarter FY 2022 to $475 million in the third quarter FY 2023, representing a 32% decline.
The company had previously reported that productivity issues and higher-than-expected costs experienced at three of its drug-product and drug-substance manufacturing facilities in Bloomington, Indiana, and Brussels, Belgium, would materially and adversely impact the company’s financial results for the fiscal third quarter and that it would delay the release of its quarterly results. The company released its results on June 12, 2023.
Source: Catalent
Chemicals/Chemical API Manufacturing
Euroapi to Increase Capacity of Controlled Substances
Eurioapi, a recent spin-off from Sanofi and a CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, has announced several initiatives to increase its production capacity for several APIs listed as essential medicines by French authorities.
Euroapi’s Francopia subsidiary, which is dedicated to production of controlled substances, will invest in R&D activities at its site Vertolaye, Puy-de-Dôme, France, to increase production of morphine and its derivatives, as well as their antagonists used as antidotes, by 2027.
At the plant-extraction stage, the company aims to develop a process that could increase productivity between 20% and 30%. At the chemical-synthesis stage, Euroapi plans to invest in more technologies and equipment that would enhance production capacity by 15% to 20%.
Once the R&D projects have been successfully completed, Euroapi plans further investments to increase its production capacity. Total investments could reach EUR 70 million ($76 million), split approximately 15% in R&D and 85% in capital expenditures, which would be deployed from 2026. These investments will be partially funded by the Government of France via France 2030, a national investment plan.
Source: Euroapi
C2 Pharma Gains OK for DMF of Digoxin in China
C2 Pharma, a supplier of ophthalmic and niche active pharmaceutical ingredients (APIs), reports that its drug master file (DMF) for digoxin, an API manufactured by its Polish manufacturing partner Nobilus Ent, has been approved in China. The approval covers both digoxin and digoxin micronized. The DMC supports different dosage forms, including oral and injectable drug-product formulations. Digoxin is derived from the leaves of the Digitalis lanata plant and as a cardiac glycoside, it is commonly used in clinical practice for the treatment of mild-to-moderate heart failure.
Source: C2 Pharma
Biologics Manufacturing
Charles River Launches Off-the-Shelf Lentiviral Vector Plasmids
Charles River Laboratories, a Wilmington, Massachusetts-based CRO/CDMO, has launched off-the-shelf-lentiviral vector plasmids for use as starting materials in viral vectors.
Source: Charles River Laboratories
Formulation Development/Drug Product Manufacturing
Croda Breaks Ground on Excipient Mfg Facility
Croda has broken ground on a new excipient manufacturing facility in Lamar, Clinton County, Pennsylvania.
The company is investing in the new 23,680-square-foot facility to manufacture excipients for drug-delivery systems used in therapeutic drugs such as mRNA vaccines and gene-editing therapies. The facility will support the production of lipids already used in therapeutics and vaccines, such as COVID-19 vaccines, and therapeutics being developed, including lipids used for cancer treatments.
Construction will begin this year (2023) with the new capacity anticipated by 2025. This facility, part of an 80-acre multi-purpose cGMP site, was purchased by the company in 2021, and will add up to 50 new jobs, including roles in engineering, administration, maintenance, operations and logistics.
Source: Croda