CHEMICAL-SYNTHETIC SERVICES in APAC
Apeloa CDMO provides world-class discovery, development, and manufacturing services for Active Pharmaceutical Ingredients (APIs), Intermediates, and Registered...
About the plant
Apeloa CDMO is the contract manufacturing focused business of Apeloa, with strategically developed its business towards becoming one of the world´s premier contract service organizations. Supported by a global network of manufacturing, development, and analytical facilities, Apeloa CDMO provides world-class discovery, development, and manufacturing services for Active Pharmaceutical Ingredients (APIs), Intermediates, and Registered Starting Materials (RSMs). The company´s commitment to leading-edge science, best-in-class customer service, and regulatory compliance drives its success in the CDMO industry
3 global R&D centers: Boston, USA --- Function in Q2 2024; 16,000 sq ft; 40+ chemists in two years; Tech Development Platform/Lead optimization/Screening/Tox Batch preparation Shanghai, China --- 68,000 sq ft; 300+ chemists; Screening/Process development/optimization/CMC Hengdian, China --- 88,000 sq ft; 250+ chemists; Process optimization/Tech transfer/CMC
8 manufacturing sites with cGMP, ISO9001, ISO14001, OSHAS18001 and IPMS certifications, 4 sites passed US FDA, 3 sites passed PMDA, 2 sites passed EDQM
Total chemical synthesis capacity: 11,000 m³ (Stainless Steel/Glass/Hastelloy/Titanium alloy/Teflon)
Total bio-production capacity: 6,570 m³ (Stainless Steel)
3 new multi-functional API workshops for parallel productions at varied scales (658 m³ in total)
High Potency API Facility for clinical & commercial scale (75 m³ in total)
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- ECOVADIS
- World Health Organization (GMP / HACCP)
- NMPA (China GMP)
- PMDA/MHLW (Japan GMP)
Activity
- CHEMICAL-SYNTHETIC, SERVICES, RSM (Raw Starting Materials), Intermediates, API (Active Pharmaceutical Ingredients), Building Blocks manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- DEA: N/A
- BSL:
- Therapeutic areas: N/A
- 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, 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, > 10,000 L
Services
- Development services, Manufacturing services, Analytical / QC services, Packaging, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies execution, Tech transfer, Pilot plant, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Primary packaging, Secondary packaging, Labeling, Salt screening, Crystallization screening, Chiral resolution screening, Milling, Fill and finish, Safety studies, Solid form selection, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis
