EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS
503B HUMAN DRUG OUTSOURCING
|Providing high-quality sterile preparations that are produced with industry-leading automation and quality control systems.|
Effective March 6, 2018, all compounded sterile preparation (CSP) labels offered by Fagron Sterile Services (FSS) will be updated. No more manual review for database entry!
New NDCs are here and FSS preparations are now listed in all of the most commonly subscribed drug database compendiums, including:
This update empowers your facility to efficiently incorporate drug profile information for integration with:
All FSS NDCs will be featured on the CSP labeling in both the GS1 compliant barcode and in human readable form for scanning and visual verification where appropriate. All drug profiles will begin to appear in your preferred drug information compendiums during the month of March.
Please contact Customer Service (1.877.405.8066) or your Sales Representative with any questions.
Wichita, KS – June 20, 2017 – JCB Laboratories (JCB) and Fagron Sterile Services (FSS), companies of Fagron North America, announce they have been awarded a contract with Premier Inc., a leading healthcare improvement company which operates one of the nation’s largest Group Purchasing Organizations (GPO). Premier unites approximately 3,750 hospitals and more than 130,000 other provider organizations that represent over $50 billion in annual purchasing power. The agreement offers a robust and trusted line of ophthalmic preparations, including combination pre-operative dilation drops, antibiotics, mitomycin, retrobulbar blocks, and intracameral mydriatics to Premier members. Fagron has supplied millions of high-quality preparations for ophthalmic procedures since 2004.
"We are extremely pleased to partner with Premier to provide high-quality ophthalmic preparations to their membership", stated Rita Hoke, President of Fagron North America. “This partnership represents an important step forward in Fagron’s strategic growth."
JCB and FSS provide sterile preparations that are produced with industry leading automation and quality control systems. Every batch is held in quarantine and undergoes rigorous quality control testing prior to release to customers. JCB and FSS are FDA registered and State Board of Pharmacy licensed.
JCB Laboratories (JCB) and Fagron Sterile Services (FSS), companies of Fagron, are FDA-registered 503B Human Drug Compounding Outsourcing Facilities located in Wichita, KS. As part of the only vertically integrated compounding pharmaceutical organization in the country, JCB and FSS are uniquely positioned to use the highest quality active pharmaceutical ingredients (APIs), produce and test preparations with confidence, and deliver cGMP compliant finished preparations with 24/7 pharmacist support. JCB and FSS specialize in ophthalmology, corticosteroids, operating room (OR) syringes, urology and dialysis preparations. Contact us today at www.fagronsterile.com.
Fagron North America is a group of innovative, scientific pharmaceutical companies that focus on optimizing and innovating pharmaceutical compounding. As the world’s leading pharmaceutical compounding company, operating in 32 countries, we act locally and think globally. Fagron North America is fully integrated with facilities that specialize in 503A Compounding, 503B Human Drug Outsourcing, and providing pharmacists with high quality APIs, supplies, education and technical support. Fagron North America is headquartered in St. Paul, Minnesota. Experience more with Fagron. For more information, visit www.fagron.us/more.
JCB Laboratories is now providing new information about a plan to expand and relocate its Wichita headquarters.
The business, a sterile injectable compounding pharmacy, is in the midst of a $15 million project to convert the former 50,000-square-foot B/E Aerospace building at 8710 E. 34th Street North into new clean-air labs to make injectable pharmaceuticals. Shipping and receiving areas, offices and a conference room also are part of the project.
I spoke to company president Brian Williamson about the project Thursday. He says the renovation is progressing and should be done this fall. He anticipates being able to move some equipment into the space in September.
Williamson expects JCB will be fully operational in its new space by November.
JCB will relocate from the 8,000-square-foot space it is in now at 8420 E. 34th Street North, a site the company moved to in 2012.
Williamson says the new space will allow for more automation.
He says two pieces of robotic equipment are being constructed now and will be installed later this year. One piece of equipment will be used for filling syringes. The other will be used to add eye drop medicine to bottles.
The new headquarters also will feature a 12,000-square-foot clean room. JCB has a 2,000-square-foot clean room now. Clean rooms create a pollutant-free, controlled environment in which products can be manufactured. The larger space also will allow the company to pursue expanded product offerings.
“It just gives us an opportunity in this new regulatory environment to pursue opportunities that weren’t there before,” Williamson says.
He says JCB will be able to do more contract manufacturing and hopes to be able to conduct clinical trials for pharmaceutical companies.
JCB plans to more than double its employee count over the next two years.
The company has 40 employees now and likely will grow to 80 to 100.
Sauerwein Construction Co. Inc. is the general contractor for the project. Spangenberg Phillips Tice Architecture is the architect.
JCB Laboratories was sold last year to Fagron, a pharmaceutical compounding company based in Rotterdam, the Netherlands.
JCB now operates under Fagron North America.
Williamson says the acquisition has given JCB new access to capital to pursue expansion.
The $15 million represents the single largest capital investment Fagron has made in 25 years in business.
He says JCB Laboratories is doing business as Fagron Sterile Services. The JCB name, however, will be used because it is a recognized brand across the U.S., Williamson says. “Our ultimate vision is to be the model for safe, high-quality sterile compounding in North America,” he says.
And it’s happening in Wichita.
May 7, 2015, 4:12pm CDT
Wichita Business Journal
MIAMI – Fagron North America, a leading supplier of compounded medications to hospital pharmacies and patients, will open one of the largest 503B human drug outsourcing facilities in the U.S. in November utilizing automation not yet seen in the nation’s sterile compounding industry.
Operating as Fagron Sterile Services, the new 50,000-square-foot facility in Wichita, Kansas, will feature a 12,000-square-foot clean room, automated pharmaceutical compounding systems, and expanded product offerings. The new facility, located near JCB Laboratories’ current facility, represents the largest capital investment that Fagron has made in its 25 years in business.
“Our ultimate vision is to be the model for safe, high-quality sterile compounding in North America,” said Brian Williamson, PharmD, former president of JCB Laboratories and the new president of Fagron Sterile Services. “Our goal is to work with the FDA so that our facility might serve as a training site for FDA inspectors and inspectors for other regulatory bodies. Fagron aims to work collaboratively with the FDA and to set the standard for the rest of the industry.”
Before being acquired by Fagron in December 2013, JCB Laboratories ranked as one of the nation’s top sterile compounding companies. Pharmaceutical compounding is an essential part of health care that enables prescribers and pharmacists to fulfill the worldwide growing need for tailor-made medication and for the production of drugs that are commercially unavailable.
JCB Laboratories is known for the investments it has made in its sterile facilities, as well as the reliability of its product quality and delivery. The acquisition by Fagron began in 2013 when Williamson was working with legislators in Washington, D.C., on new legislation to regulate sterile compounding.
“We wanted to know how Europe had handled similar situations,” Williamson said. “A colleague introduced us to Fagron. They came to Wichita the next day and saw our facility. By the time they left, I had an invitation to go to Europe to see how Fagron operates.”
JCB Laboratories, founded in 2002, was not new to the idea of being acquired. “We had a strategic buyer and investment groups looking at us already,” Williamson said. “At the same time we were looking to redefine the standards for sterile compounding, Fagron was also looking for an established category leader to be its platform for growth in the U.S.”
JCB Laboratories will operate under Fagron’s new divisional structure, though Fagron will rely on JCB Laboratories’ proven method of sterile compounding and reliable product delivery.
“We immediately saw a U.S. company that could be the vanguard for our U.S. expansion in sterile compounding,” said Jake Jackson, Fagron North America President. “JCB Laboratories has been a company of vision with a culture of constant improvement and the proven ability to execute. What they needed was the product development and capital resources a global company like ours provides.”
Williamson said he was excited about Fagron’s aligned values, trust and cultural fit. “Fagron is a youthful, entrepreneurial, R&D company with the vision and resources to seriously reshape and redefine the sterile industry in the U.S. and globally,” said Williamson.
The Wichita expansion by Fagron will increase the size of JCB Laboratories’ current facilities by six times. This will bring new scalability to the U.S. that will ensure the availability of more sterile products, which has long been a concern for providers, pharmacists and patients.
“For so many years, the use of automated equipment made sterile compounding facilities look like manufacturers. It was certainly frowned upon. Now, with the Drug Quality and Security Act (DQSA) in place and outsourcing facility registration with the FDA, if you don’t have automation, you’re out. Sterile manufacturers have proven that automated production equipment is the safest, most reliable way to get products to patients,” Williamson said. “With Fagron, we’re building it now. Bigger. Faster. Stronger. It’s all coming together.”
Fagron North America is a group of innovative, scientific pharmaceutical companies that focus on optimizing and innovating pharmaceutical compounding across the U.S. Fagron North America is a leading supplier of pharmaceutical raw materials, equipment and supplies, concepts and compounded medications to hospital pharmacies and patients. Fagron North America is fully integrated with significant capabilities in research, development, manufacturing and distribution. Fagron North America is headquartered in Miami, Florida.
Miami – Fagron North America has officially launched Fagron Academy, the most progressive compounding and clinical training facility in the United States. Fagron Academy will advance pharmaceutical compounding in the US with the resources only available through the global market leader Fagron.
Enrollment is now open for Fagron Academy’s first regional symposium in February, with non-sterile and sterile compounding training courses to begin in March.
The Academy’s course-based tuition offers relief from the industry-standard membership model, but that is just the first of several important advantages for compounding professionals, according to Academy Director Craig Hitchman.
“We seek to elevate and enhance compounding through training and support to consistently deliver the most innovative and highest-quality pharmaceutical compounding services,” Hitchman said. “Our programs extend well-beyond traditional training to create a progressive learning hub for this specialty practice area. As the global market leader in pharmaceutical compounding, we believe Fagron is best- positioned to drive this evolution.”
The Academy’s integrated programs combine didactic lectures with hands-on, interactive labs. Courses are designed to equip compounding professionals with the latest practice skills in a manner that ensures they are immediately applicable in the delivery of patient-centered care. The dedicated full-time faculty is supported by a roster of national and international compounding experts who serve as guest lecturers.
Fagron Academy’s $3mm facility was designed by G. Alvarez Studio Inc. to combine ultra functionality with clean, modern aesthetics. The facility features a 7,800 sq. ft. compounding training space with a fully equipped, non-sterile training laboratory and a 1300 sq. ft., ISO-certified clean room designed by Clean Air Technology.
“We are a global resource that will be unrivaled in the U.S.,” Fagron North America President Jake Jackson said. “Our facility, personnel and global experience will bring a new wave of compounding knowledge to our customers. Further, it doesn’t hurt that our customers’ educational experience will be 15 stories up in warm, sunny downtown Miami!”
*Article source https://us.fagron.com