Since 2009, Alpha is specialized in R&D and manufacturing of pharmaceutical excipients in China. Site area 67,000m2 with 32,500m2 excipient workshop, strictly implements cGMP guidelines and passed China unannounced GMP inspection, Certified by EXCiPACT GMP.
The quality strictly conforms to current ChP, USP-NF, BP, EP, JP. Including but not limited to support customized particle size, micronized powder, spray granulation process and microorganism control to meet diverse functional specifications.
Our Service
Customized excipient/ Free sample.
One-stop technical support from R&D, scale-up to commercialization.
Strict quality control, conform to international standards, meet multiple applications
Site audit from customer and official.
NMPA CDE Registeration.
Excipient bundling review.
DMF document/Regulatory compliance.
Facilities
Our company currently has a production workshop of 32500m2, equipped with multiple production lines such as fully automated production lines, injection grade production lines, and solid dosage excipient production lines, the annual production capacity exceed 4000mt.
The QC laboratory is equipped with instruments such as HPLC and GC-MS to ensure that key indicators such as microorganisms and impurities are qualified, and strictly follow pharmacopoeia standards.
High-end production technology is adoped such as low-temperature ultra-fine grinding, spray granulation, molecular distillation, etc., to achieve indicator control and meet customized demand.
Social Responsibility
Safety, environmental, social responsibility, quality and efficiency are the key corporate goals of Alpha. Alpha takes important responsibilities for human beings and environment. We firmly believe that corporate benefits are social benefits.
Alpha strives to provide professional services for customers, grow together with partners, provide development space for employees, create value for society, actively undertake social responsibilities, and strive to achieve harmonious development between the company and customers, partners, employees and society.
To supply superior excipients for human health.
Culture
Move Forward with Co-operation, Mission-acomplish Guarantee.
Goals: Safety, environmental, social responsibility, quality and efficiency.
Alpha takes responsibility for human beings and the environment.
Corporate benefits are social benefits.
To supply superior excipients for human health.
Quality Assurance System
