FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in North America
Pharma CRO/CMO
About the plant
COMPANY PROFILE
The company is an innovative organization based in a city in Canada, specializing in the design and synthesis of novel organic molecules to support and accelerate early-stage drug discovery for pharmaceutical and biotech firms. It applies unique synthetic strategies and robust execution to create both simple and complex organic compounds, making the drug discovery process more efficient, cost-effective, and compliant with the highest quality standards.
Founded in 2009 in a city in Canada by the founders, both accomplished scientists with over 20 years of experience in organic synthesis, medicinal chemistry, drug discovery, pharmaceutical process R&D, pilot studies, scale-up, and technology transfer to commercial pharmaceutical manufacturing.
BUSINESS MODEL, NICHE & CORE EXPERTISE
- The company designs and develops innovative synthetic routes for manufacturing pre-clinical drug compounds and intermediates in multi-gram quantities for clients worldwide, accelerating pre-clinical in vivo and in vitro drug discovery across various therapeutic areas. Its methods are eco-friendly, scalable, and cost-efficient.
- It conducts process R&D and technology transfer for the production of key starting materials and advanced intermediates in multi-kilogram scale for APIs used in clinical studies and generic API manufacturing.
- The company develops novel synthetic routes for producing deuterium-labeled drug standards and metabolites supporting generic drug development.
- It is also specialized in process R&D and technology transfer for the manufacturing of semiochemicals (from multi-gram to multi-kilogram scale) used in crop protection applications.
Certifications
- ISO
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
- ANVISA (Brazil B-GMP)
Activity
- FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Radiopharmaceuticals, Building Blocks manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): N/A
- DEA: N/A
- BSL: N/A
- Therapeutic areas: (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (V09-10) Radiopharmaceuticals, (V01) Allergens
- Markets: FDA (USA), EMA (EU), CDSCO (India), ANVISA (Brazil)
Batch Size / Reactor
- Small, Medium, Large, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L
Services
- Development services, Manufacturing services, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Tech transfer, Pilot plant, Research batches, Scale-up, Pilot batches, Batch records, Chiral resolution screening, Customized block synthesis, Impurity synthesis
