Site Area: 1,200 m²

No. of Employees: 42

Regulatory Approval Status: Chinese GLP-China/US cGLP-USA (Pending)/EU GLP-Germany (Pending) 

R&D Capability: We have the capability to finish lab production by end of the 1^st month, scale-up production by the end of the 3^rd month and realize commercial production by the end of the 6^th month with well qualified EHS system guarantee.

Innovative and efficient synthetic & analytical development capabilities.
 
State of the art laboratory with equipments simulating large scale manufacturing machines including sifters, mills, granulators, fluid bed dryers & processors, compression, coating & blister packing machines.
 
Pre-formulation laboratory to conduct drug-excipient compatibility study, product-package integrity testing, stability study as ICH requirements, physical characterization of API and powder mechanics.
 
Pilot plant facilities for manufacture of pilot batches for tablets and capsules.
 
Capacity of process development requisite for scale up.   

BSPC’s R&D Centre is manned with 42 dedicated research scientists and equipped by sophisticated modern analytical instruments. It consists of four dedicated teams:

Pharmaceutical Chemistry Team -- Development of chemical synthesis process technology, study on impurities with targeted APIs;

Pharmaceutical Analysis Team -- Testing method development and validation for APIs and dosages, samples testing for Pharmaceutical Chemistry Team and Formulation Team; 

Formulation Team -- Formulation and manufacturing process development for solid oral dosages, liposome dosages, sustained release and controlled release dosages;

QA Team -- Quality assurance for the R&D, regulatory affair handling for product registration in China and oversea countries, protocol drafting, reviewing and approval for pre-formulation development, specification development, process development, testing method development and validation.

Major Equipments for R&D: