Olon USA is a US-based CDMO offering integrated chemical development, synthesis and manufacturing services to the pharmaceutical, biotech and specialty-chemical industries.

Description

Olon USA — formerly part of Ricerca Bioscience — is the US-arm of Olon Group, a global leader in active pharmaceutical ingredient (API) manufacturing and generics supply. The company provides an integrated offering of chemical synthesis and biological-processing services, combining decades of experience across multiple geographies. With a consolidated network of manufacturing plants globally and a strong R&D backbone, Olon USA positions itself as a reliable partner for pharmaceutical, biotech, food, chemical and bio-industrial clients requiring flexible, compliant and cost-effective solutions. Olon USA operates under the “Five Strong Pillars” concept — a framework designed to consistently meet and exceed customer expectations across all engagements.

Key Products & Services

Chemical Development & Process Chemistry: From early‐phase development through to commercial manufacturing, Olon USA supports clients in process chemistry, synthetic chemistry and chemical development.

Analytical Chemistry & Testing Services: On-site analytical chemistry services to support quality control, impurity profiling, stability analysis — essential for API development and regulatory submission.

Engineering & Manufacturing Services: Including pilot plant, kilo-lab (cGMP), and larger scale batch manufacturing; enabling small-molecule API production from initial development through to clinical and commercial supply.

Small-scale API Production (Kilo Lab): Specialized facility for small-batch API production — ideal for early phase clinical supply or small-volume commercial needs, with flexibility and regulatory compliance.

Process Development & Scale-up: Expertise in tackling challenging chemistry (e.g. chiral, diastereoselective molecules), impurity synthesis and purification, ensuring a robust, scalable and regulatory-compliant manufacturing route.

Regulatory Support & Compliance: Full quality management system aligned with GMP, compliance with ICH Q7 and CFR 210/211 guidelines, DEA compliance where needed; strong regulatory-affairs support and global regulatory filing capabilities.

Olon USA represents a mature, well-integrated CDMO partner that combines deep chemical expertise, robust quality and regulatory systems, and flexible manufacturing infrastructure. Its integration within the global Olon network ensures access to broader capabilities — from small-scale API synthesis to large-volume manufacturing — making it well suited for pharmaceutical and biotech clients requiring a single, reliable outsourcing partner. With its disciplined project-management, commitment to quality and cost-effectiveness, Olon USA offers a compelling value proposition for organisations seeking efficient and compliant chemical development and manufacturing services.

Contact Information

Phone
Address
Concord, OH Florham Park, NJ

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