Huayi Pharmaceutical (Anhui) Co. Ltd. is an EU-GMP approved manufacturer specialized in development and manufacturing of oral solid and liquid dosage forms including high potency products. The company is the first Anhui-based company passing EU certification. As a contract development and manufacturing organition (CDMO), especially for Chinese and EU markets, we have granted EU GMP certificate in August 2010 and passed the GMP inspection by Medicines and Healthcare Products Regulatory Agency (MHRA) from the UK. The company also has passed the quality inspections by multinational companies including Teva, KrKa and Novars.
Huayi has successfully developed and transferred more than 70 products since its establishment. The company has been supplying the UK and EU markets with annual output of nearly 3 billion tablets/capsules.
Integrated Service of High-end
Pharmaceutical R&D and Production
Pharmaceutical CRO / Clinical practice / Testing / Registration Application / Ormulation CMO
Type
Scope
Vantagem
Service value
One-stop Preparation CDMO Service
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Preparation Development
Chemical API Synthesis -
Development of multi dosage forms to meet the diversified development demands of customers;
Synthesis and development of chemical drug to prevent market monopoly and reduce cost of API
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Phase I/II/III Clinical Trials
SMO Services
Inspection Services -
Project experience in multiple areas of innovator drugs to meet customer demands;
Clinical collaboration within the EU system;
Mature project inspection experience
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Biological Sample Blood Test
Genotoxic Impurity Test -
Certified by CNAS; Comply with ISO/IEC 17025 requirements;
Compliant quality system for MA application in China and Europe;
Led by a Team of Doctors and Postgraduates.
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MA application in China
MA application in Europe -
A comprehensive Chinese and European dual quality management system;
Meet the requirements for MA application in China and Europe;
One product can be simultaneously submitted for approval in both Chinese and European markets to maximize customer value.
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Commercial production of preparations
Production for clinical batch of Innovator drugs -
Dedicated CMO for oral preparations, focused on the MAH service;
Mature procedure for the project and commercial orders management;
Flexible production capacity with comprehensive conditions for simultaneous production of different products.
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1. Provide one-stop service from chemical synthesis to commercial production so as to save customer management input and speed up the progress of project application.
2. Possess professional procedure to carry out CDMO business efficiently with more than 10 years' experience in providing preparations for China and EU markets and ability to help customers build MAH management system.
3. Comply with quality system requirements in China and Europe.
MAH solutions provider and Joint venture cooperation service provider;
Focus on development of multiple dosage forms and manufacturing of oral preparations, Providing chemical synthesis as supplementary service;
An open CDMO service platform for international markets;
Making quality products with reliable technology and delivering excellent customer service;Open for various cooperation approaches, Maximize customer value!
Type
Scope
Vantagem
Service value
-
MAH solutions provider and Joint venture cooperation service provider;
Focus on development of multiple dosage forms and manufacturing of oral preparations, Providing chemical synthesis as supplementary service;
An open CDMO service platform for international markets;
Making quality products with reliable technology and delivering excellent customer service;Open for various cooperation approaches, Maximize customer value!
One-stop Preparation CDMO Service
1. Provide one-stop service from chemical synthesis to commercial production so as to save customer management input and speed up the progress of project application.
2. Possess professional procedure to carry out CDMO business efficiently with more than 10 years' experience in providing preparations for China and EU markets and ability to help customers build MAH management system.
3. Comply with quality system requirements in China and Europe.
Integrated service of
High-end Pharmaceutical R&D
and Production
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100+
APIs currently in use
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3billion
tablets/capsules delivered to Europe every year
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50+
quality audits passed
