Noramco introduces controlled substance development solutions
The company is integrating its API development offering to include all of the technologies and services that generic and branded pharmaceutical producers require to advance solutions to market. The specialty API producer has introduced a comprehensive development-to-manufacturing platform to provide its customers with more technically sound solutions, under one roof, with less complexity.
“Noramco has fine-tuned its business to serve as a solutions provider” said Jim Mish, CEO and President. “We now provide all of the expertise and assets that customers require to rapidly advance novel controlled API solutions from clinical to ready-to-implement commercial products,” Mish said.
“We are here at CPhI Worldwide to showcase the pillars of our business that afford our customers the option to accelerate the development of their products in a flexible customer-friendly manner,” said Bill Grubb, VP Global Strategy and Innovation.
Dossier development of differentiated products for customers
Noramco and SPI Pharma, a global leader in the manufacture and supply of functional excipient platforms and drug development services, have signed a letter of intent to develop and license formulation packages, specifically for implementation by their customers. The companies intend to deliver “ready-to-implement” patient-friendly drug formulations that provide convenience, compliance, and efficacy for such therapeutic indications as intense pain, opioid addiction, and central nervous system conditions (epilepsy, migraine, etc.).
The partnership will bring together API and functional excipient science to deliver innovative patient-friendly solutions to formulators of finished dosage forms. This development service is an addition to the API services Noramco already supplies, which include formulation-friendly particle sizes, analytical data, and stability studies.
“Our intention is to provide our customers with unique presentations, including all the elements of a full dossier, ready to manufacture at their facility," said Grubb.
Custom synthesis of controlled APIs
Most recently, Noramco upgraded its small-volume manufacturing suites in the US. The flexible high containment suites have controls in place to produce compounds of OEL<500 μg/m3. Special adaptions in-suite design, equipment design, operations and process safety afford developers a one-stop location to produce parenteral and high potency controlled substances supported by a rapid response team to execute against client needs for clinical-to-commercial APIs.
Noramco is moving forward with a broad offering of clinical to commercial scale cannabinoid APIs for branded and generic pharmaceuticals. The comprehensive offering includes everything a drug manufacturer requires to advance cannabinoid-based APIs to finished dosage forms.
New controlled APIs
Noramco is also moving forward with its broad offering of clinical- to commercial-scale cannabinoid APIs for branded and generic pharmaceuticals. The comprehensive offering includes amphetamine salts, methylphenidate hydrochloride and tapentadol hydrochloride as well as Cannabidiol, Dronabinol, and other related cannabinoids.
“One of the leading producers of specialty APIs, Noramco holds both the development and regulatory expertise required to bring virtually any controlled API to market, anywhere in the world,” Grubb said. “As we further expand our technology portfolio, our customers may come to us for APIs that address a greater diversity of medical conditions.”
Earlier this year, Noramco obtained patents for chemical synthesis of Dronabinol, Cannabidiol, and derivatives in high yield and high stereospecificity. These patents allow production of high-purity, stable synthetic material.
Distribution partnership for Europe
Earlier this year Noramco expanded its portfolio and geographic reach to better align with market needs. To ensure generic and branded pharmaceutical product makers have access to the company’s expanding portfolio and solutions services throughout Europe, Noramco has signed a letter of intent with Azelis, a value-adding distributor with expertise in controlled APIs. Azelis maintains application laboratories and warehouses throughout Noramco’s European service area and is capable of accelerating product and reference standards delivery. Azelis joins existing distribution partners, Midas and IMCD.
Reference standards portfolio now available online
Noramco offers well characterised, highly purified analytical reference standards for routine analysis, method validation and development, commercial investigations, stability studies and other product development activities. Companies that hold a DEA license may now order impurity reference standards from Noramco directly online from a new highly secure website. This new website provides analysts, formulators, and developers rapid access to more than 175 reference standards products to accelerate their product development programmes.
For more information about Noramco’s controlled API product and service offerings, visit Noramco at CPhI stand 111A21.