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Shandong Risen-Sun Pharmaceutical Co. LTD. will become a respected pharmaceutical enterprise with professional competitive advantage and international competitiveness.

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CDMO

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Shandong Risen-Sun Pharmaceutical Co. LTD

CDMO Service introduction

Founded in 2013, with over 220 customer-centric employees, Shandong Risen-Sun Pharmaceutical Co. LTD focuses on providing small molecule and new modalities CDMO services for pharmaceutical clients. Our comprehensive CRO & CDMO platform is engaged in the research and development, manufacturing and supply of regulatory starting materials, novel building blocks, intermediates, reference compounds, APIs and drug products. We are a one-stop service platform to support our client’s projects from early drug discovery, process development to commercialization. Over the past years, we have established a state-of-the-art QC/QA system aligning with ICH guidelines for pharmaceutical manufacturing. We provide our clients with high-quality products and CMC services across the entire life-cycle of drug development.

What We Offer

Shandong Ruishun Pharmaceutical Co., Ltd.

Synthetic Chemistry

① Scale up from milligrams to kg scale Building blocks, reference compounds, intermediates, chemical reagents, impurities, isotopic label, etc.

②Custom synthesis services Small molecules.

Process Development for APIs and Intermediates

① Synthesis process development and optimization ② Process validation and technology transfer

③ API synthesis for toxicological batches and IND submission④ GMP manufacturing for clinical studies

API and Intermediate Manufacturing

Commercial Plants----- Shandong Risen-Sun Pharmaceutical Co. LTD.

① Total Area：--1286,000 ft²② 6 GMP production line, scale up to hundreds of kgs per batch, 4 lines in plan③ Reactors：--320, range from 200L- 5000L ④Total volume: --800,000L

Key Technologies----Reaction types

Metal-catalyzed cross coupling, Chiral synthesis, Chiral resolution, Enzyme catalyzed reaction, Low temperature metallo-organic reactions, High temperature/pressure reactions, Pd-carbonylation, C-H activiation, Heterogeneous hydrogenation, Asymmetric (transfer) hydrogenation Bases, acids or Lewis acids catalyzed capability Amide-formation Chiral acids/bases resolution , Metal scavenger screening, salt-formation and crystalline polymorphs identification, Flow hydrogenation, Flow nitration, Enzymatic reactions using immobilized enzyme. Preparative Chromatography Service.

Formulation Facilities

Eqipment	Site	Area	Total reaction volume/L	Eqipment mateials	Eqipment Type	Total No.
Reactor	High-tech factory	Synthetic area	42703	SST/GL/Glass	2L-3000L	105
	High-tech factory	Clean area	6050	SST/GL	5L-1000L	17
	Ningyang factory	Synthetic area	79800	SST/GL	200L-2000L	90
	Ningyang factory	Clean area	6500	SST/GL	500L-2000L	6
Filter/Centri fuge	High-tech factory	Synthetic area	1470	SST/HALAR	800mm-1250mm	9
	High-tech factory	Clean area	650	SST/HALAR	600mm-800mm	5
	Ningyang factory	Synthetic area	3260	SST/HALAR	800mm-1000mm	21
	Ningyang factory	Clean area	650	SST/HALAR	800mm	5
Dryer	High-tech factory	Synthetic area	2409	SST/GL	Square dryer、Biconical、Rake dryer	19
	High-tech factory	Clean area	177.4	SST/GL	Square dryer、Biconical、Rake dryer	4
	Ningyang factory	Synthetic area	4400	SST/GL	Rake dryer	11
	Ningyang factory	Clean area	3900	SST/GL	Biconical、Single cone dryer、Rake dryer	12

Analytical Development and Quality Control

① State-of-the-art instruments ② Analytical chemistry ③ Complete quality management system ④ Stability Study

Drug Product

Commercial Plants----- Jewim Pharmaceutical(Shandong) Co., Ltd

• MDI & Spray Plant was established in 2002, dedicated to the production of inhalation aerosol and spray. Which has five automatic MDI filling lines introduced from Pamasol, Switzerland and Italy automatic lines for assembly, spray testing and online weight double-checking machines. The annual capacity can achieve 60 million packs. The plant has passed TGA GMP certification for three times with the highest level A1.

• Multi-Dosage Form Plant was founded in 2004, covering an area of about 130000 m², mainly produces sterile inhalation solution, dry powder inhalation (DPI), solid preparation, liquid preparation, small volume parenteral (SVP) and APIs, etc.

• International advanced production equipment, including: Switzerland Rommelag BFS (three-in-one) machine, German Harro Hoefliger DPIs filling machine, German GEA high-speed blender, German Glatt granulator, IMA capsule filling machine, tablet compression machine and other international top equipments to improve the production capacity, meet the requirements of data integrity and traceability, improve production efficiency and quality control level, as well as minimize errors and pollution caused by human operation.

Contact Phone

0086-0538-8923092

E-mail

risensun@jewim.com.cn (Corporate Affairs）

risensun-sales@jewim.com.cn(Enquiry & Cooperation)

Company Address

No. 668 Hengxin street, economic development zone, Ningyang county, Taian city

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