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Noramco introduces controlled substance development solutions at CPhI Worldwide

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The speciality API producer introduced a comprehensive development-to-manufacturing platform to provide its customers more technically sound solutions

Noramco 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 speciality API producer introduced a comprehensive development-to-manufacturing platform to provide its customers 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. “The announcements we are making today provide the framework for Noramco as a one-stop resource for novel API development and unique dosage form solutions.”

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.

New Controlled APIs

Noramco, a global controlled-API supplier with 40 years of experience, also continues to expand its portfolio of technologies to better serve the needs of its global customers. These include the 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.”

Distribution partnership for Europe

Earlier this year, Noramco announced a strategic framework to unlock the full potential of its business by expanding its portfolio and geographic reach to better align with market needs. To ensure generic and branded pharma 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.

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