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Manufacturing

SERVICE AREAS & COMPETENCES

FACILITY OVERVIEW

Manufacturing facilities & storage: 20,000 sq. ft.

Capability of waste water disposal: 50 tons per day

Utility: frozen saline water cooling, compressed air, soft water

Steam: centralized supply by the industrial park

Non-GMP kilo lab: 17 reactors from 50-100L

cGMP Kilo lab: 5 reactors from 100-200L

Non-GMP pilot plant with 20 reactors with capacity from 300L-5,000L

Core Competences

Robust Quality Management

Sundia’s Quality Assurance Unit (QAU) has established a FDA cGMP compliant quality system to ensure the quality of its services and products. Our employees are trained and qualified in all aspects (operational, safety, data integrity, confidentiality, etc.) prior to working independently on our clients’ projects. Hundreds of SOPs were established to ensure the quality of service from raw materials to final products, from laboratory to pilot plant, and from operator to chief executive officer. Sundia has successfully passed hundreds of audits from global pharmaceutical companies and health authorities around the world

Quality Assurance

We have standard operating procedures, training management, good documentation practice, archive management, material management, specification management, vendor qualification and contract manufacturer qualification, calibration and maintenance, quality incident management, including deviation, OOS, customer complaint, and product recall as well as change control , validation and qualification management, package and label management, internal audit and routine inspection

At our Taicang plant, we are ICH Q7 compliant and have four level documentation framework, batch record reviews, change control and deviation investigation, CoA review and approval, robust training program and over 200 QA related SOPs in place

Environmental、Health、Safety

EHS policy

Strictly complies with all applicable national and local EHS laws, regulations and standards

Suitable internal SOPs are well established and implemented for EHS controls

EHS Accountability

EHS Department is responsible for providing guidance, robust training for all of hazardous reactions, field safety, regular safety assessment report and other safety related issues

Sustainability

Strictly control the discharged quantity of waste, improve the wastes treatment ability to minimize the environmental impact

STRONG TRACK RECORD IN SMALL MOLECULE DEVELOPMENT

Clients Indications Sundia Support
Amount Status Description
US Rare Disease 2kg (2013) , 8 kg (2014) Phase III Providing GMP starting material
US Oncology 15kg (2013~2014)
20kg (2015~2016)
Phase II/III API production
US Oncology 5kg (2015~2016) PCD API production
US Oncology 150kg (2015~2016) PCD Providing GMP starting material
Canada Breast cancer 30kg (2015~2016) Phase I API production
Korea Inflammatory disease 4kg (2014), 10kg (2015~2016) Phase II API production
Korea Oncology 20kg (2015~2016) PCD Providing GMP starting material
Korea Antibiotics 5 kg (2014) PCD Providing GMP starting material
Korea Lung cancer 1500kg (2013~2014)
1500kg (2015~2016)
Phase III Providing GMP starting material
EU Chemotherapy-induced Neuropathic Pain 1 kg (2015) Phase I API process develop
7 kg (2015) Providing GMP starting material
Australia N/A 10kg (2015~2016) PCD API/GMP starting material
EU Rare Disease 100kg (2015~2016) Phase III Providing GMP starting material
UK N/A 100kg (2015)
200kg (2016)
Phase I Provide Material for GMP production
China Anti-HIV 20kg (2015~2016) Phase I API production
China Oncology 30kg (2016) Phase I Providing GMP starting material
China Oncology 100kg (2015~2016) PCD Providing GMP starting material
China Antilipemic 10kg (2015~2016) Phase I API production
China Lung cancer 5kg (2014)
10kg (2015~2016)
Phase I API production
China Oncology 5kg (2015) Phase I API production
Taiwan Periodic Paralysis 2kg (2015) PCD API production
Japan N/A 100kg(2015), 500kg (2016) N/A Provide Material for GMP production
Japan N/A 1kg (2015), 40kg (2016) N/A Provide Material for GMP production

IND Filing Projects:

Classification Pharmacology Indications
Chemical Drug 1.1 RR inhibitor Cancer
Chemical Drug 1.1 Multi targeted RTK inhibitor Cancer
Macular degeneration
Herbal Medicine 5 Non hormones Endometriosis
Chemical Drug 1.5 Prescription Common cold
Chemical Drug 1.1 NP inhibitor Cancer
Chemical Drug 1.1 Neuroprotectant Stroke
Chemical Drug 1.1 ALK/MET inhibitor Cancer
Chemical Drug 1.1 LDLR regulator Hyperlipoidemia
Chemical Drug 1.1 Multi targeted RTK inhibitor Cancer
Chemical Drug 1.1 b-RAF inhibitor Cancer
Chemical Drug 1.1 Protease inhibitor Cancer
Chemical Drug 1.1 mTOR inhibitor Cancer
Chemical Drug 1.1 NS3-4A Protease inhibitor HCV
Chemical Drug 1.1 Multi targeted RTK inhibitor Cancer
Chemical Drug 1.1 MEK inhibitor Cancer
Chemical Drug 1.1 Pro drug Leukemia
Chemical Drug 1.1 Multi targeted drug Senile dementia
Chemical Drug 1.1 PARP inhibitor Cancer
Chemical Drug 1.1 Peptide Pro drug Cancer
Chemical Drug 1.1 Confidential Diabetes
Chemical Drug 1.1 Confidential Cancer
Chemical Drug 1.1 Antivirus Confidential
Chemical Drug 1.1 Confidential Cancer