Noramco™

Purisys General Manager, Josh Hoerner, appears in PharmaTech Magazine discussing the qualification of material suppliers being a crucial step in ensuring safe and effective drug products. “As a CDMO, we also need to consider and provide input on CMC [chemistry, manufacturing, and controls] aspects of the API or excipient such as chemical manufacturing process capability, analytical method capability and limits, compendial quality standards, control of impurities (such as genotoxic impurities and nitrosoamines)”

Purisys has activated a new Drug Master File (DMF) for nalmefene hydrochloride, a key solution for acute opioid overdose treatment. This milestone reinforces our commitment to delivering high-quality, US-based APIs that support pharmaceutical innovation. "By making nalmefene available for reference, we are both expanding our portfolio, as well as reinforcing our commitment to providing essential solutions for opioid overdose treatment that meet the highest standards of quality, efficacy and safety," says Joshua Hoerner, General Manager and Executive Vice President of Purisys. To learn more about this news and how we can help streamline your drug development process, visit https://loom.ly/8X7xp2g.

We’ll be in Beantown for Biotech Week Boston. Visit us in Booth 1607 from September 23-26 to meet our team and discuss how we can partner to propel your #API and other chemical synthesis projects. Whether you're an emerging biotech or a large pharma company, you can rely on us and our collaborative approach to help you achieve your goals. For event info: https://loom.ly/jQW0oGw To learn more about Purisys and our capabilities: https://loom.ly/NOOVWjQ

I am excited to be attending CPHI Milan from 8th to 10th October 2024 representing the Noramco Group of companies including Purisys, Noramco™. Halo Pharmaceutical, Inc. & Halo Pharmaceutical Canada We're sharing booth 5C110 with our good friends from Woodstock Sterile Solutions and look forward to seeing old friends as well as current and potential customers. Come and see us to discuss your #API; #customsynthesis; #drugproduct needs. Feel free to contact me directly to arrange a meeting. www.cphi.com

Ready to take your #molecule from concept to commercialization? Meet with Amber Burch and Jennifer Peroni at ChemOutsourcing September 3-6, and discuss how we can help you develop, and manufacture your #API – especially complex, difficult-to-manufacture #therapeutics. For event info and to register: https://loom.ly/MwfBaBQ To learn more about Purisys and our capabilities: https://loom.ly/NOOVWjQ #ChemOutsourcing #pharmaceutical #CDMO #smallmolecule #clinicalsupply

With deep scientific knowledge and a collaborative approach, Purisys is a unique #CDMO partner for your custom #APIsynthesis. We leverage 40+ years of experience and 300+ commercial reference standards to get your product to market faster and more efficiently. https://purisys.com/

Interesting and important article on the benefits of intranasal #Nalmefene v intranasal #Naloxone. The results showed that IN nalmefene showed a significantly greater reduction in the incidence of cardiac arrest compared to IN naloxone after simulated overdose with fentanyl and carfentanil. A dose of fentanyl (1.63 mg) caused cardiac arrest in 52.1% of patients (95% CI, 47.3-56.8); IN nalmefene reduced this rate to 2.2% (1.0-3.8) compared to 19.2% (15.5-23.3) IN naloxone. Nalmefene also demonstrated substantial reductions in cardiac arrests in opioid-naïve individuals. Across dosing scenarios, 4 simultaneous doses of IN naloxone were needed to reduce the percentage of cardiac arrest to levels produced by a single dose of IN nalmefene Purisys has just completed commercial validation of Nalmefene API and will be filing a USDMF soon. Please reach out via our website and we can discuss how we can support your life saving products with quality API. https://lnkd.in/eyvPM5t9

**PRESS RELEASE**  Kane Biotech Inc. (TSX- V:KNE; OTCQB:KNBIF) (“Kane Biotech” or “Kane”) announces that it has made its first commercial-scale sale of revyveTM Antimicrobial Wound Gel product (“revyveTM”) to ProgenaCare Global LLC (“ProgenaCare”). Kane has now completely fulfilled its obligation related to the USD$500,000 initial manufacturing scale up fee received upon signing an exclusive distribution agreement for the US wound care market in May 2023, after receiving U.S. Food and Drug Administration 510(k) clearance for revyve™ Antimicrobial Wound Gel. Kane has subsequently been working with Halo Pharma on the technology transfer and manufacturing scale-up phases of product commercialization. “This is another major milestone for Kane,” said Marc Edwards, President & CEO. “There has been a significant buildup of interest and demand for revyve™ amongst ProgenaCare’s customers as well as Kane’s existing and potential distributor network globally.” “We are delighted to have revyveTM in full scale commercial production,” said Howard Walthall, CEO, ProgenaCare Global. “The feedback from patients and clinicians on the product from our limited initial launch has been excellent. With ample quantities now available, we look forward to being able to help even more patients along their healing journey.” Kane recently presented new in vitro data on the efficacy of revyve™ Antimicrobial Wound Gel at the Symposium on Advanced Wound Care (SAWC), Special Operations Medical Association (SOMA), and Medical Technology Enterprise Consortium (MTEC) conferences. Kane also announces that it has signed a four-year commercial manufacturing services agreement with Halo Pharma for the manufacturing of revyveTM.  Manufacturing will take place at Halo Pharma’s cGMP compliant pharmaceutical manufacturing and packaging facility located in Mirabel, Quebec. “We worked closely with Halo over the last year during the technology transfer and scale-up phases,” said Mr. Edwards. “We will be placing orders for revyve TM at full-scale manufacturing volumes as we look forward to meeting market demand for this product.” Read the full press article: https://rb.gy/zvbas4 #biotech #kanebio #biofilm #chronicwounds #wounds #woundcare #woundhealing #health #medical #medicaldevice #ProgenaCare #research #patent #FDAapprovedProduct #woundgel #revyve #partnership #distribution

We're #hiring! Noramco is a leading specialty active pharmaceutical ingredient (API) development and manufacturing company that supports the advancement products in a range of therapeutic applications. Founded in 1979, the company is headquartered in Delaware and maintains operations around the world. We have an open position for a QA Specialist at our Wilmington, DE facility. If you are interested and meet the minimum requirements as laid out in the link below, we'd love to hear from you. https://lnkd.in/ehb_FPmv

We're #hiring. Purisys is a trusted CDMO partner for custom pharmaceutical API and other chemical synthesis projects with capabilities unique in the industry. Built over a 40-year history, our expertise allows us to support a diverse range of custom API development projects from proof of concept, bench chemistry to full-scale product commercialization – with particular strengths in full-service clinical Phase I/II and small volume, orphan drug commercial API GMP synthesis We're looking for a Senior Quality Assurance Specialist to be based at our Athens, GA facility. If interested, you can find the full job description and apply via the link below: https://lnkd.in/eB87MN7s