FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in Europe
Solutions for non Viral Delivery programs
About the plant
Curapath, is a global CDMO specialized in the tailored design, development, and GMP manufacturing of cutting-edge polymer and lipid-based drug delivery systems. Our customers benefit from our unique expertise, operational excellence and technical solutions in polymer nanoparticles (PNPs) and lipid nanoparticles (LNPs) along with their essential components. In addition, we have extensive experience in drug conjugation and cross-linking, to increase stability, reduce toxicity, and enhance bioactivity. At Curapath, we stand as your partner from discovery stages to commercial GMP scale-up. With our dedicated support, expertise, and state of the art manufacturing capabilities, we assure you a guaranteed path for your drug to navigate through clinical development and reach commercialization seamlessly Your success is our commitment
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
Activity
- Implants, Sterile forms (ophtalmic, nasal, otic), Topical, mucosal and transdermal, Injectables, Terminal sterilization, Fill&Finish, Bottles, Tubes, Sprays, Patches, BFS (Blow Fill Seal) ampolues, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), Flexible bags / Infusion systems, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, SERVICES, Excipients, Building Blocks manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
- DEA: N/A
- BSL: 1, 2, 3
- Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (P) Antiparasitic products, insecticides and repellents
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium, 1 - 10 L, 10-100 L, 100 - 1,000 L
Services
- Regulatory services, Development services, Manufacturing services, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Genetic analysis & Pharmacogenetics, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, DMF (Drug Master File) preparation and submission, Chiral resolution screening, Fill and finish, Safety studies, Customized block synthesis
