Come see us at the 2019 Society of Nuclear Medicine and Molecular Imaging Annual Meeting at the Anaheim Convention Center June 22 – 25, Anaheim CA, Booth #975
Compounding is necessary in special cases, but your nuclear pharmacy could also be supplying your hospital with lower-standard copies of FDA-approved radiopharmaceuticals without your knowledge1,2.
“Because compounded drugs are not FDA-approved, FDA does not verify their safety, effectiveness, or quality before they are marketed. … In addition, and of particular concern, poor compounding practices can result in serious drug-quality problems, such as contamination or medications that do not possess the strength, quality, and purity they are supposed to have. This can lead to serious patient injury and death.1“
-FDA’s Human Drug Compounding Progress Report
YOU ARE AT RISK
Individuals in a hospital can be held legally responsible when patients are harmed by improperly compounded products.2
YOUR INSTITUTION IS AT RISK
The use of non-FDA-approved nuclear medicines can negatively impact your institution’s quality of patient care, potentially tarnish its reputation, and lead to legal and financial liabilities.2
YOUR PATIENTS ARE AT RISK
Subpar compounded nuclear medicines can lead to misdiagnosis due to low-quality imaging. Even worse, compounded sterile products have become contaminated, causing patient harm and even deaths.
ASK YOUR NUCLEAR PHARMACY TODAY FOR DOCUMENTATION THAT THEY ARE SUPPLYING ONLY FDA-APPROVED RADIOPHARMACEUTICALS.
References: 1. FDA’s human drug compounding progress report three years after the Drug Quality and Security Act. U.S. Food & Drug Administration. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM536549.pdf. Accessed August 31, 2018. 2. Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D.2013;13(1):1-8. 3. Kainer MA, Reagan DR, Nguyen DB, et al. Fungal infections associated with contaminated methylprednisolone in Tennessee. N Engl J Med. 2012;367(23):2194-2203. 4. Smith RM, Schaefer MK, Kainer MA, et al. Fungal infections associated with contaminated methylprednisolone injections. N Engl J Med. 2013;369(17):1598-1609. 5. Gupta N, Hocevar SN, Moulton-Meissner HA, et al. Outbreak of Serratia marcescens bloodstream infections in patients receiving parenteral nutrition prepared by a compounding pharmacy. Clin Infect Dis. 2014;59(1):1-8.
With all Pharmalucence products either fully transferred or in process for transfer to our Billerica MA facility, we have closed our original facility in Bedford MA.
Thanks for the memories!
The new Lyophilizer is the same make and model as our existing Lyo, and will be tied to our existing Bosch automated and isolated aseptic filling line. The project is expected to be completed by May 2017.
The Pharmalucence manufacturing site located at 29 Dunham Rd., Billerica, MA has received FDA approval for drug product aseptic fill-finish manufacturing operations. Our Tc 99m Sulfur Colloid Kit will be the first product manufactured at this new facility. Pharmalucence is now in the process of transferring the manufacturing process for all of its other injectable products to this site.
Dear Pharmalucence Customer:
It is my pleasure to announce to you that Pharmalucence has been acquired by Sun Pharmaceuticals (www.sunpharma.com), a world leader in the development and marketing of generic drugs.
Pharmalucence chose to join the Sun Pharma family of companies to accelerate our growth and diversification. Combining our advanced parenteral production capabilities and Nuclear Medicine product
line with Sun Pharma’s extensive experience, resources and global presence in generics will take Pharmalucence’s business development much further, in less time, than could have been achieved under our previous private ownership.
As a Pharmalucence customer, you will have no disruption from this ownership transition. Our people, our products and our business will continue to operate as in the past, but from within the larger Sun
Pharma company. Continued investment in our nuclear medicine business, including development of new products and expansion into international markets, is planned. In addition, expansion of Pharmalucence’s advanced drug production platform will be implemented, further enabling the
manufacture of existing and new injectable pharmaceuticals for the U.S. market.
There is one change in business plan related to our new ownership. With our integration into the larger Sun Pharma drug production network, Pharmalucence has fully subscribed its production capacity and will not seek additional Contract Production customers. Ongoing support of existing Contract Production customers will continue to be an important part of our business operations.
Thank you for your business and continued support. We look forward to the next phase in Pharmalucence’s development as a Sun Pharma company and our ongoing relationship with you. If you have any questions regarding this news, please don’t hesitate to contact us.
Glenn Alto Vice President and General Manager Pharmalucence Inc., a Sun Pharma company
MikRon Inc. to assume IBL 437C service business effective August 6, 2014. To contact MikRon for IBL 437C service, please contact them at (508) 589-4600 or email Jim Thomson at Jim@mikroninc.com.
Download the PDF for more details below:
Pharmalucence has achieved a significant milestone on its way to bringing its new aseptic drug production facility in Billerica, MA into full operation. On April 29, we submitted our DMF, a comprehensive description of facility equipment, operations and validation, to the FDA. This step will be followed by submission of our Prior Approval Supplement (PAS) for transfer of the production of our Sulfur Colloid kit to the new facility. The PAS submission will trigger an FDA inspection as the last step toward final approval. This inspection is anticipated within four months from the time of our sending the PAS. Assuming an acceptable FDA inspection, Pharmalucence expects to begin drug manufacturing at the Billerica, MA site in early Q4 of this year.
If you are a parenteral drug manufacturing professional, please contact us to learn more about this complimentary two-day conference hosted by Bosch Packaging Technology, Pharmalucence and other industry sponsors. The purpose of the conference is to further the understanding of the issues and technologies associated with aseptic pharmaceutical manufacturing.
The conference will include presentations from industry experts and case studies of real world applications. We will also encourage peer to peer group discussions of the issues affecting the industry today.
There will be networking opportunities throughout the event and a half day tour of the Pharmalucence facility on the second day providing additional opportunities for knowledge sharing. Topics will include:
- Relevant Industry case studies
- Regulatory issues: the changing landscape
- New facility design: what do you
need to know?
- Risk mitigation: best practices
- Build or outsource?
- Future industry trends
- Single use technology in the final fill process
For more information, see our Event web site: http://goo.gl/YuuTp