Oakwood Labs is currently manufacturing FDA-approved commercial injectable pharmaceutical products in our aseptic GMP facility, under robust quality systems and cGMP. Our compliance history is public, but we can provide a summary to you upon request.
We manufacture standard injectable products on a contract basis in partnership with other pharmaceutical companies. In the area of standard injectable products, we specialize in aseptic manufacturing, lyophilized products, and high potency compounds.
For sustained release injection products, it is our preference to manufacture and supply the products, for which we charge standard contract manufacturing rates. In situations where the demand would outstrip our capacity, or if a secondary supplier is deemed worthwhile, our equipment train is portable, and can be transferred to another manufacturer.
At Oakwood Labs, we specialize in the development, scale-up, and aseptic manufacturing of commercial injectables. Read on to learn about the capabilities that we have for commercial injectable manufacturing along with more on our commercial pharmaceutical manufacturing facility.
Our Commercial Injectable Manufacturing Capabilities
As a committed commercial injectable manufacturer, we offer true versatility for our clients. With our commercial pharmaceutical development manufacturing facility, we offer the following capabilities:
- Small volume injectables
- Liquids, suspensions, microsphere products, lyophilized parenterals
- Controlled substances for class III and class IV
- Ability to work with products that require an aseptic filling process
- Clinical trial material for phases I, II and III
- Commercial supply
- Ability to create products for both humans and veterinary use
By offering these capabilities throughout our commercial injectable development process, we continue to provide value to each and every partner that we work with.
Our Commercial Pharmaceutical Manufacturing Facility
At Oakwood Labs, we are committed to maintaining an aseptic manufacturing facility that is FDA approved, and we continue to be a reliable provider for commercial injectable manufacturing. Our facility includes the following features:
- Microbiology and QC analytical laboratories
- Raw material dispensing and weight
- Equipment preparation and staging
- Aseptic formulation and filling
- Aseptic lyophilization
- Vial capping
- Inspecting, labeling and packaging
- Shipping, receiving and warehouse space
Our aseptic manufacturing facility has its own building automation system as well as a nitrogen distribution system. Our facility is ISO classified and has WFI and Clean Compressed Air generation and distribution systems. We also utilize chemistry and microbiology labs, along with a temperature-controlled warehouse.
Ensure Quality with Our Commercial Injectables
We credit our proven history of compliance to our thorough, in-house quality systems. All of our commercial injectables and processes have to be verified through our quality control department and go through an extensive process.
Our process includes documentation control, internal audits, investigations and evaluations. This quality system ensures that all products that are manufactured within our facility will remain safe, pure, and effective throughout the product lifecycle.
Contact Oakwood Labs for Commercial Injectables
Are you in need of commercial injectable development services? Rely on us to remain compliant throughout the process while you receive quality commercial injectables. Reach out to Oakwood Labs today to get started. We look forward to helping you through our services.