Apeloa Pharmaceutical Co., Ltd.

Apeloa Pharmaceutical Co., Ltd.

Apeloa CDMO provides world-class discovery, development, and manufacturing services for Active Pharmaceutical Ingredients (APIs), Intermediates, and Registered Starting Materials (RSMs).

About the plant

 

Apeloa - Science-Driven Solutions with Global Scale

Apeloa CDMO is the contract discovery, development and manufacturing division of Apeloa Pharmaceutical Co., Ltd., a subsidiary of the Hengdian Group, one of China’s largest private enterprises. With over 30 years of industry experience, Apeloa stands as a trusted partner to global pharma and biotech companies, offering full-spectrum solutions from early-stage development to commercial-scale GMP production.

Strategically positioned across three continents, our state-of-the-art facilities and multidisciplinary teams deliver high-quality APIs, Intermediates, and Registered Starting Materials (RSMs)—all backed by robust regulatory compliance, innovation in process design, and best-in-class customer service.

 

Core Capabilities

• API Process Development & Manufacturing
• High-Potency API (HPAPI) – OEB4 & OEB5
• Flow Chemistry
• ADC Payloads & Linker Development
• Synthetic Peptides
• Lipid Nanoparticles (LNPs – CLs, ILs, PEG-Lipid)
• PROTAC/TPD Molecule Manufacturing
• Medicinal Chemistry (Med. Chem)
• Full-Time Equivalent (FTE) Research Support
• Analytical Development & Quality Control
• Global Regulatory Affairs & CMC Filing
• Formulation Development & Manufacturing

 

Global Footprint

Corporate Presence: 

Headquarters: Hengdian, China
Frankfurt am Main, Germany | Boston, USA | Tokyo, Japan

R&D Centers of Innovation 

Location	Facility Size	Scientists	Focus Areas
Boston, USA	16,000 sq ft	40+	Tech development, lead optimization, screening, tox batches
Shanghai, China	68,000 sq ft	300+	High-throughput screening, process development, CMC
Hengdian, China	88,000 sq ft	250+	Tech transfer, process optimization, CMC

 

Manufacturing Infrastructure

• 8 globally manufacturing sites

              Certifications: cGMP, ISO9001, ISO14001, OSHAS18001, IPMS

              Full regulatory reach: US FDA, EMA, PMDA, NMPA, KFDA, and more

•  Production Capacity

              Chemical Synthesis:

                 - Total area: 11,000 m³

                 - Reactors: 50 L - 45,000 L

                 - Output API: 4,000 MT/year

                 - Intermediates: 38,000 MT/year

              Bio-Production:

                - Total area: 6,570 m³

                - Reactors: 50 L - 120,000 L

                - Output API: 2,000 MT/year

                - Intermediates: 2,000 MT/year

              HPAPI:

                - Total reactor volume: 75 m³ (clinical & commercial scale)

                - OEB 4 (PDE = 10 - 100 µg/day)

                - OEB 5 (PDE < 10 µg/day)

              Multifunctional API Workshops: 658 m³ for parallel production

 

Why Choose Apeloa CDMO?

Reliable. Responsive. Globally Certified – Apeloa CDMO delivers flexible, science-led manufacturing with a global footprint. Whether you’re scaling a molecule or accelerating commercialization, we’re the partner that moves with your vision.

 

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• ECOVADIS
• World Health Organization (GMP / HACCP)
• NMPA (China GMP)
• PMDA/MHLW (Japan GMP)

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Activity

• CHEMICAL-SYNTHETIC, RSM (Raw Starting Materials), Intermediates, API (Active Pharmaceutical Ingredients), Building Blocks manufacturing

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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

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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

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Services

• Development services, Manufacturing services, Analytical / QC services, Packaging, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies execution, ICH Stability studies, 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, Co-crystal screening, Polymorph 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

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