Partnership struck to increase production of DEA controlled substances
Noramco selects AFC for its infrastructure and analytical capabilities to help meet growing demand.
Noramco, a producer of controlled substances for the pharmaceutical industry, and AMPAC Fine Chemicals (AFC), a manufacturer of APIs with cGMP facilities in the US, has announced a strategic partnership to produce certain US DEA controlled substances for use in the treatment of addiction, abuse prevention, cannabinoids for clinical indications, and for the treatment of attention deficit hyperactivity disorder (ADHD).
Noramco will continue to be the marketer and will utilize AFC as the contract manufacturer to supplement existing Noramco capacity.
The DEA Schedule II and III controlled substance APIs are bulk actives for regulated pharmaceutical finished dose customers. These drug substances require high-quality cGMP production assets and sophisticated analytical equipment to meet very precise quality requirements.
AFC recently registered its large-scale controlled substance manufacturing plant in Petersburg, VA, with the DEA further adding to existing state-of-the-art controlled substance manufacturing capabilities at Rancho Cordova, California. The Virginia facility gives Noramco the extra capacity it needs to meet growing demand, and a support facility to complement its in-house capabilities in Wilmington, Delaware.
Noramco President and CEO, James Mish said: “We investigated a number of sites and partners but only AFC has both the infrastructure and analytical capabilities in place that not only meet but exceed our expectations. AFC operates with excellence in both quality and reliability.”
“AFC brings core capabilities like our own. It’s the first company we have found that integrates well with Noramco’s operations and strategic focus. As the abuse deterrence, cannabinoids, and ADHD markets expand and diversify, be it new compounds, or development of traditional products for use in novel delivery systems, Noramco is making new innovations possible for customers, providing everything that’s required to go to market reliably, safely, and on schedule,” Mish said.
Dr Aslam Malik, President and CEO of AMPAC Fine Chemicals, added: “AFC has enjoyed a long-standing relationship with Noramco in supporting the production of their controlled substances. AFC's strategic objective is value-created growth achieved by continuing to serve our key customers through excellent relationship management, by expanding our product lines, and applying our core technologies to their critical needs.”
“The foundation of this growth is established through AFC's Core strengths in Process R&D and Process Engineering. Noramco’s demonstrated commitment to excellence in their products, people and customer support closely aligns with AFC’s. We are delighted to be in partnership with Noramco,” Malik said.
Related News
-
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Pharma Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain. -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News BIOSECURE Act continues to loom over Chinese pharma manufacturers
With the US BIOSECURE Act on its way to passing into legislation, Chinese companies are facing declining revenues within the first half of 2024 as US pharmaceutical and healthcare companies pull their businesses from the country. -
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance