Pharmaceutical manufacturing facility expansion
QuVa Pharma is expanding its biotech pharmaceutical manufacturing facility in Bloomsbury, New Jersey, US as part of its multi-year growth spree to extend its pharmaceutical facilities beyond Texas.
The expansion will increase the company’s production and distribution capabilities at the New Jersey site.
Bain Capital Private Equity, an alternative investment firm, is supporting the development and expansion plans of the facility, along with other partners and external investors, including Silicon Valley Bank and Oxford Finance.
The current phase of the expansion will be completed by the fourth quarter of 2019, while the entire expansion project is expected to be completed by 2020.
QuVa Pharma purchased a manufacturing facility from Garibaldi Group, a real estate company, on July 2016 and purpose-built it to comply with the Food and Drug Administration (FDA) and other regulatory requirements.
The facility is strategically situated close to Route 78, Interstate 95 corridor and Newark Liberty International Airport, western New Jersey. It is well-connected to several distribution sites in Pennsylvania, Ohio, New York and New England, as well as numerous south-eastern markets. It is also suitably positioned for potential expansion in future.
QuVa Pharma’s existing manufacturing plant in Bloomsbury is an FDA 503B-registered facility covering an area of 160,000ft², featuring two interconnected buildings, with future expansion into a state-of-the-art 240,000ft² facility by improving the cleanroom. The facility expansion will be cGMP-compliant and added with operation capacity for running a second shift.
The facility will help to serve customers with a wide range of ready-to-use compounded sterile medications sourced from various starting materials such as FDA-approved pharmaceutical formulations and active pharmaceutical ingredients (APIs) and will also supply medicines during drug crisis.
The facility uses specialised sterile compounding technique for developing medication in an environment free from infectious microorganisms such as virus and bacteria.
The technique is utilised to produce high quality compounded sterile products delivered to the hospitals present in the critical markets in the eastern part of the US.
The company has two 503B registered outsourcing facilities including one in Sugar Land, Texas, for aseptic manufacturing and another in Temple, Texas.
The facilities feature closed compounding units with restricted access to reduce product contamination risks. The products undergo extensive United States Pharmacopeia (USP)-71 testing to check sterility, as well as other potency and endotoxins, before the final delivery to the customers. The facilities follow some of the strictest standards for patient safety in the industry.
The facility was expanded to include two manufacturing suites (Suites 4 and 5) on September 2018, doubling the total output of the company.
Founded in 2015, QuVa Pharma is a pharmaceutical products supplier that serves as a national platform for offering sterile compounded preparations in the US, in various sectors including cardiovascular, anaesthesia, obstetrics, general medicine and pain management.
The company also provides medical devices such as syringes, speciality class IV admixtures bags, cassettes for pumps and PCA vials.
The company is licensed to supply the compounded products, ranging from bulk drug substance to drugs for reducing drug shortage, into all the states of the country. Some of the most commonly requested medicines outsourced by the company are Morphine, Oxytocin, Fentanyl, Ephedrine, Epinephrine and Neostigmine.
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