This overview explores Ritedose, the largest U.S. pharmaceutical CDMO, and how its aseptic Blow-Fill-Seal technology supports large-scale branded and generic drug manufacturing.
Introducing Ritedose
As we finish celebrating our 30th year, we thought we’d take a step back and re-introduce ourselves! Who is the Ritedose Corporation, what do we do, and how and why do we do it?
Ritedose is the country’s largest pharmaceutical contract development and manufacturing company (CDMO) that specializes in aseptic Blow-Fill-Seal (BFS) technology. We use BFS to manufacture branded drugs for other pharmaceutical companies, as well as generic drugs that are no longer under patent protection. Ritedose has the capacity to produce more than 2.6 billion doses every year for a diverse customer base of startups, major pharmaceutical companies, wholesalers and retail pharmacies.
The History and Growth of Ritedose Since 1995
We started in 1995 with just 11 people in a 52,000-square-foot facility, making 42 million doses annually. Today, we employ over 600 people who work in facilities totaling more than 500,000 square feet capable of 2.6B+ doses a year. For the past 25 years, we’ve had a flawless track record of reliability, and since 2012, we have delivered more than 12 billion doses with no interruptions. We maintain this level of quality to ensure that patients always have access to safe and reliable medicine. After all, it’s the patients who are at the heart of everything we do.
But it’s not just patients who drive our mission. We’ve also invested in our community, supporting local and national organizations through financial contributions and volunteer efforts. This year, we launched the 1,000 Hours of Purpose initiative, dedicating company time to serving the South Carolina Midlands community. We’re also considered an employer of choice in the Midlands, fostering a culture of excellence, purpose and professional growth.
So, what makes Ritedose, Ritedose?
Passion and Precision with a Purpose. What Ritedose Does as a CDMO
Defining Contract Development and Manufacturing for Pharmaceuticals
First, we’re a leading CDMO. Contract development and manufacturing starts with the earliest stages of clinical trials, supporting the process through New Drug Application filings with the U.S. Food and Drug Administration (FDA), to scaling up production, commercial manufacturing in our facilities, and ultimately, filling and finishing and distributing the drug to our customers and their patients. Our work can start at any point along this journey to drug delivery.
Recently, we became the manufacturer of Verona Pharmaceuticals’ newly approved drug for chronic obstructive pulmonary disease, Ohtuvayre. The drug is the first new type of treatment for COPD in more than 20 years.
Drug Development Support from Formulation to Fill and Finish
As we are showcasing the largest U.S. Blow-Fill-Seal Technology, Our CDMO products include solutions, emulsions and suspensions for inhalation, ophthalmic, optic and oral drugs. Container types include standardized inhalation ampules, ear drops, eye drops and some unique patented designs.
Ritedose Generics and Approvals for High-Demand Medications
Why Generics Matter for Patient Access and Affordability
Ritedose Pharmaceuticals is also a leading generic drug supplier. Generics are medicines with the same active ingredient as brand-named drugs, but that no longer have the same patent protections. This allows other companies to make the products, leading to generics being less expensive than the branded counterparts, but they are manufactured under the same regulations and safety standards as branded drugs.
Generic drugs play a vital role in making essential treatments more accessible, and at Ritedose, we never compromise on quality or safety to ensure patient care. With the largest portfolio of nebulized inhalation therapies available, we are uniquely positioned to serve wholesalers and retail pharmacy chains with reliable solutions—all under one roof.
2025: Three New Generic Drugs and Expanding Our Portfolio
- In May, we announced that we were granted approval by the FDA to manufacture and market generic formoterol fumarate inhalation solution (20 mcg/2 mL), a treatment for chronic obstructive pulmonary disease (COPD) and other respiratory ailments.
- We also received FDA approval for manufacturing and distributing generic Albuterol Sulfate Inhalation Solution, 0.5% (2.5 mg/0.5 mL)*, helping address a national shortage of the much-needed respiratory drug. *Potency expressed as albuterol, equivalent to 3 mg of albuterol sulfate
- And most recently, we received FDA approval to manufacture tobramycin inhalation solution, increasing our nebulized portfolio to be the largest in the nation, and adding our first cystic fibrosis (CF) product.
Blow-Fill-Seal Technology at Ritedose
Whether as a CDMO or generics powerhouse, Ritedose makes all of its products using Blow-Fill-Seal technology. In short, BFS is a closed system that forms, fills, and seals the products in a continuous manufacturing process:
- Blow—the container is formed by blowing the parison (typically a low density polyethylene) into a mold, creating the container’s shape.
- Fill—then, the container is filled with the drug product. Each dose is delivered accurately through time/pressure filling.
- Seal—the container is then sealed as the top section of the molds come together.
Industry Growth and Ritedose Recognition as a Blow-Fill-Seal Technology Leader
BFS is taking the pharmaceutical world by storm. There has also been growing crossover into other industries with interests in aseptic processing, such as food and personal care products. It’s estimated that the BFS market, now in excess of $3.1 billion, will grow by 6.8% every year through 2033, when it’s estimated to total $7 billion.
Ritedose is a leader in BFS, consistently ranking as one of the top five pharmaceutical companies in the world using this technology. In fact, we were chosen by the Pharmaceutical Blow-Fill-Seal International Operators Association (BFS-IOA), the global trade association for Blow-Fill-Seal Technology users, to hold its American meeting at Ritedose, in Columbia, SC for 2025.
Expanding Capacity and Operational Excellence
We have expanded our capacity for development and manufacturing, installing two additional high-speed BFS lines that add 360-million-unit doses for ophthalmic and respiratory medications.
We’ve also added a seventh Syntegon packaging line, doubling our capacity to pack individually wrapped medications in vials.
As the largest U.S. CDMO using BFS, we’ve had a 100% customer retention rate over 25 years and a flawless track record of reliability, delivering billions of doses since 2012 with no patient interruptions.
Commitment to Quality and Compliance Standards
Rite the First Time Quality Philosophy
How can Ritedose do this? Our professionals use their expertise and dedication to make sure we always meet FDA and cGMP standards, with our “Rite the First Time” commitment to quality.
Compliance Success with FDA and National Pharmacy Boards
In fact, Ritedose has an exceptional inspection and compliance history by the FDA, state boards of pharmacy, US Pharmacopeia, and the National Association of Boards of Pharmacy. We are also always working to minimize waste and delays and therefore, doubt. We are constantly improving our processes to consistently approach our goal for zero manufacturing errors.
Quality Testing Methods in Chemistry, Microbiology, and Validation
More than anything else, pharmaceutical companies are searching for the highest quality, and at Ritedose, we’re maintaining our track record by giving it our full attention. This means methods in wet chemistry, chromatography and instrument analysis to detect formulation imperfections and impurities; microbiology and real-time environmental monitoring to ensure sterility; validation methodology from spreadsheets, equipment, cleaning and sterility assurance; and quality assurance with integrated ERPs, e-documents, electronic batch records, supplier management and change management systems.
How Ritedose Partners with Customers
We also work closely with our customers. There’s no “one size fits all” concept here at Ritedose. For decades, we’ve helped customers achieve transformative growth and scale-up ambitions with tailored processes, from early phase clinical trials to commercialization. Our formulation capabilities include sterile filtration, bulk sterilization, potent compounds, oxygen- and temperature-sensitive products (from 160 to 3,600 liters in an ISO 8 classified area), and our average time from formulation to shipment for commercialized products is between 18 and 20 days.
Who We Are—Beyond Manufacturing
We always say that patients are at the heart of what we do. So, who are we? Our employees put their heart, soul and brainpower into getting safe drug delivery right the first time, every time. We foster a culture of excellence, purpose and professional growth for our current employees.
And, we’re building a future workforce by partnering with colleges and universities across South Carolina, developing top industry talent.
Our Commitment to Community Impact
Our 1,000 Hours of Purpose initiative with the United Way of the Midlands donates 1,000 hours of employee time to support various local organizations addressing basic human needs like hunger and housing. Employees receive monthly opportunities for a full day of volunteering with local organizations such as Homeless No More, which supports people who are temporarily unhoused; Home Works of America, which provides home repair services to low-income homeowners; Palmetto Place, a safe shelter for homeless youth in South Carolina; and Transitions, which helps move previously unhoused people into new homes. Also, last year we marked $66,000 in fundraising for the American Heart Association’s Field Day events.
And last but not at all least, we are donating one million doses of our products to the national charitable medication distributor, Dispensary of Hope, to provide respiratory medications to low-income and chronically ill patients nationwide.
The Future of Ritedose in CDMO and BFS Innovation
We hope this gives you a solid introduction to who we are and what we’re about at Ritedose! We go above and beyond for our customers, doing whatever it takes to meet and exceed their needs. We help our customers achieve extraordinary results.
Our team is the most experienced in our industry. We help customers see around corners, avoid problems before they start, and capture opportunities before the competition. We are proud of our decades-long relationship with our customers, and the new relationships we’re forging and will continue to forge! The BFS and CDMO industries have a bright future, and we look forward to working with you to be a part of it!
