Synthetic Pharmaceutical Drugs and Intermediates ： Contract R&D/GMP Manufacturing
As a distributor of multiple CDMOs in Taiwan, we provide professional services that will assist you in contract research and development/manufacturing intermediates, APIs, and synthetic pharmaceutical drugs.
For API manufacturing, we support our clients in outsourcing of new drug development and generic drugs at various stages, from synthetic method confirmation to small-scale prototypes (grams to kilograms) for clinical trials, GMP production and commercial production. CDMOs in Taiwan can manufacture anticancer drugs, steroids and highly potent pharmaceuticals that require high containment, and regulatory registration. In pharmaceutical manufacturing, they can also provide contract services for the development of pharmaceutical processing, manufacturing method formulation research, quality standard setting, test method development and CMC-related operations.
CDMO, of which we are an agent, provides services strictly complying with GMP, ICH, PIC / S guidelines, etc. of each country. Even in the development stage, they will improve manufacturing methods and data management based on the premise of launching, and supporting smooth regulatory application.
1. Production technology
・ PIC/S GMP compliant production. Guarantee Sterility Assurance Levels (SAL)
・ Single use technology to reduce cross contamination
2. API manufacturing (grams to kilograms scale)
・Strong process and analytical R&D in small molecules, peptides, and peptide drug conjugates (PDC)
3. Formulation manufacturing
・ Production of oral solid dosage drug
・ Able to produce sterile finished product (e.g., powders, liquids and lyophilized powders)
・ Aseptic filling of vials, prefilled syringes and cartridges
4. Pharmaceutical platform technology
・ Osmotic-controlled release oral delivery system (OROS)
・ Pellet-coated sustained-release OD tablet
・ Oral controlled absorption system (OCAS)
・ Ultrafine crystal long-acting injection product (LAI)
5. Generic drug treatment area
Cardiovascular disease, metabolic diseases, central nervous system (CNS) diseases, epilepsy, dementia & Parkinson-Syndrome, digestive diseases, kidney diseases, urinary diseases, respiratory diseases, orthopedic diseases, infectious diseases, etc.