BrightGene Bio-Medical Technology Co., Ltd. is a fast-growing pharmaceutical company that engages in the research, development and manufacturing of special APIs , advanced intermediates and fermentation products with primary strategic focus on the high-end API market and late-stage development drug candidates.
Established in 2001, BrightGene boasts cutting-edging process R&D expertise and commercial manufacturing capabilities to serve our clients from around the globe. Our main facility includes a 6000㎡ synthesis and analysis R&D center, 5000㎡ pilot plant and 6000㎡ GMP compliant API manufacturing plant in Suzhou Singapore Industrial Park, a 1500㎡ fermentation R&D center in Chongqing,a 5 acres fine chemecial & fetmentation plant in Taixin.
We are a research based company. Through our own discovery and exploratory research efforts ,we develop non-infringing process, intermediate and polymorph, and provide our customers with non-infringing APIs or intermediates.Meanwile,we specialized in small-molecule fermentation, biotransformation products, proteins & peptides. Brightgene not only developed strains and process of complicated fermentation produces but also own advanced isolation and purification technology.We also emphasize on building and maintaining robust quality and registration systems that ensure our compliance with GMP and other regulations. This enables our customers to utilize our products directly for registration and commercialization in regulated pharmaceutical markets.
We pride ourselves in unparalleled R&D capability and robust project execution. Thus, we are pleased to offer a wide range of products, from fermentation products, custom synthesis for advanced intermediates, first-to-file, and difficult-to-make APIs with multi-step synthesis, multi-chiral centers or polymorphs, including high potency and cytotoxic drugs. We also provide services such as process optimization, analytical development, ultra-pure reference standard materials, impurity profiling and new polymorphism screening and development, isolation and purification,and much more.
Combining high productivity and cost-effective resources, along with unmatched regulatory and technical know-how, BrightGene is uniquely positioned to serve the global pharmaceutical industry, particularly the fast growing specialty pharmaceutical sector.
Finally, our commitment extends to providing excellent customer services and technical consulting for our clients, as well as forging strategic partnerships with companies and institutions whose strengths augment our own.
The USFDA inspection date：March，2013；outcome：approved.