產品與服務

Products and Services

ScinoPharm, which has established a global reputation for producing active pharmaceutical ingredients (APIs) for cancer treatment, has advanced cGMP production facilities that have passed quality inspections by the Taiwan FDA (TFDA); the EU EMA and EDQM; the US FDA, the Australian TGA, the Japanese PMDA; Korea FDA; and German authorities. Our quality and professional services are globally recognized and trusted by our partners. ScinoPharm, with its comprehensive and solid R&D capabilities, continues to develop a broad range of products such as organic synthesis and peptides of small molecules.

 

ScinoPharm’s Advantages in API Development:

Synthetic research and process development of drug candidates

  • Professionals in organic chemical synthesis
  • Capacity and equipment to develop the latest analytical methods
  • Professionals in process integration and development
  • No infringement of existing patents

Manufacturing and supply of cGMP-compliant APIs

  • CGMP quality assurance
  • Production facilities for high potency/cytotoxic drugs
  • Production capacity for high purity/low endotoxin drugs
  • Drug Master File (DMF)/full technical reports

Manufacturing and supply of commercial APIs

  • Various batch production equipment
  • Organization and implementation of QC/occupational safety and health systems
  • Various validation services
  • Most competitive cost of production

 

Manufacturing

ScinoPharm’s highly effective team of professionals, with R&D experts from Taiwan and China, together with its US Food and Drug Administration (FDA)-approved, state-of-the-art Good Manufacturing Practice (cGMP) facilities, can assure the prompt development and manufacturing of high quality, price competitive, and non-patent infringing APIs to our customers.

ScinoPharm, with its dedicated production facilities, can manufacture high potency, oncological APIs for injectable formulations. We continue to diversify our product line using non-infringing patent processes conducted under the most stringent safety requirements.

 

Small Molecule Drugs

ScinoPharm specializes in developing and manufacturing high potency, oncological APIs with a high technical threshold. ScinoPharm is one of the few API manufacturers that can provide a high potency, oncological APIs for injection formulations. We pursue an active patent application strategy to further our competitive edge because our focus is on developing propriety products and their production processes. ScinoPharm strictly monitors and ensures the quality of our products throughout every stage of development, from chemical synthesis to commercial scale-up, while adhering to the international CGMP standards. Recently, the Design of Experiment (DOE) tools and lean production management systems were introduced to improve the quality and efficiency of manufacturing and the overall process, thereby guaranteeing that process innovation is realized in all portfolio products.

 

Peptides

ScinoPharm has accumulated considerable experience in the synthetic process of peptide drugs and can rapidly synthesize peptides with high stereoselectivity and yield. Using column chromatography-based purification technology, the purity of the final product and the purification efficiency can be improved to reduce costs and increase competitive advantage.

 

CRAM Services

ScinoPharm delivers innovative R&D capabilities and cost-effectiveness. Our cGMP-compliant facilities are dedicated to the manufacturing of clinical, small-scale, and commercial-stage APIs and intermediates. We provide dedicated, fast-responding contract research organization (CRO) and contract manufacturing organization (CMO) services with analytical and regulatory support to our customers.

 

Biopharmaceuticals

ScinoPharm has constructed its own cell line for protein drug production and is equipped with the relevant production techniques. By investing in Tanvex Biologics, Inc., we are integrating multiple resources to develop biosimilars and gain solid ground in the rapidly developing market of biogeneric drugs.