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
Pharmalucence has been named as a “Rising Star” award winner for the Team Massachusetts Economic Impact Awards, awarded annually by MassEcon (Massachusetts Alliance for Economic Development). The awards celebrate companies that have made an outstanding contributions to the Massachusetts economy.
Pharmalucence receives FDA notification that Sulfur Colloid Injection (SCI) has been granted Orphan Drug designation status and seven years of market exclusivity for its use in lymph node localization in melanoma patients.
Pharmalucence has been selected as one of 19 finalists for the ninth annual MASSECON 2012 Team Massachusetts Economic Impact Awards. Finalists are selected on job growth, investment and facility expansion. The selected winners from each of the state’s five regions will be announced in October.
Glenn Alto, President and CEO, and Ed Connolly, COO, to present “Making it in Massachusetts: A Small Company’s Road to the CMO Market” at Interphex 2012.
For more details and to listen to an audio summary of their presentation visit:
Waltham, MA – The Massachusetts Life Sciences Center announced today that the Center’s Board of Directors has awarded $21.2 million in tax incentives to 28 life sciences companies. The recipient companies have committed to creating more than 940 new jobs in the Commonwealth this year.
The Life Sciences Tax Incentive Program, established in 2008 as part of the state’s ten- year, $1 billion Life Sciences Initiative, authorizes up to $25 million in tax incentives each year for companies engaged in life sciences research and development, commercialization, and manufacturing. The primary goal of the program is to incentivize life sciences companies to create new sustained jobs in Massachusetts.
The Life Sciences Act provides for ten different incentives, which address the significant capital expenditures associated with the life sciences R&D cycle and the high costs of translating research into commercially viable products. This is the third year that incentives have been provided under the program. Twenty-nine (29) companies have active tax incentive awards totaling $38.5 million awarded in 2009 and 2010. Those companies created a total of 1,588 jobs after receiving their tax incentives (1,106 of which were created by the companies under the Program).
While manufacturing operations and personnel remain in Bedford MA while our new facility project continues, all administrative staff has now relocated to 29 Dunham Road, Billerica, MA 01821. Our toll free number remains 1-800-221-7554, but some employee direct dial numbers have changed.
Pharmalucence Supplemental New Drug Application (sNDA) for the use of Sulfur Colloid Injection (SCI) in the localization of lymph nodes in melanoma patients has been accepted for review by FDA.