企業(yè)認(rèn)證

北京睿琪生物醫(yī)藥科技有限公司  

北京睿琪生物醫(yī)藥科技有限公司集食品新原料、醫(yī)藥原料及中間體、新藥用輔料等研發(fā)、商務(wù)推廣于一體的高新技術(shù)企業(yè)，倡導(dǎo)綠色環(huán)保、差異化的大健康理念；注重工藝開發(fā)的RSM研究和QbD過程研究，突出工藝的經(jīng)濟(jì)、環(huán)保、安全和質(zhì)量可控性。 公司在北京市亦莊經(jīng)濟(jì)技術(shù)開發(fā)區(qū)擁有上千平米的研發(fā)中心，下設(shè)工藝開發(fā)、中試轉(zhuǎn)化、商業(yè)化生產(chǎn)、質(zhì)量研究及商務(wù)推廣等部門。中心團(tuán)隊(duì)由多名擁有二十多年原料藥商業(yè)化生產(chǎn)經(jīng)驗(yàn)的化學(xué)專業(yè)博士、碩士組成，配套多臺(tái)50/100L玻璃反應(yīng)釜、20L旋轉(zhuǎn)蒸發(fā)儀、高效液相色譜儀、紅外光譜儀、液質(zhì)聯(lián)用儀（HPLC -MS）、氣質(zhì)聯(lián)用儀（GC-MS）等儀器設(shè)備，并在天津、河北、山東及內(nèi)蒙古等地?fù)碛卸鄠€(gè)穩(wěn)定合作的商業(yè)化生產(chǎn)基地。 公司可進(jìn)行各種高端原料藥、醫(yī)藥中間體、食品新原料和藥用新輔料等相關(guān)化合物的研究開發(fā)、商業(yè)化生產(chǎn)。同時(shí)可承接原輔料的備案登記業(yè)務(wù)，以及已有藥用原輔料生產(chǎn)工藝的優(yōu)化與改進(jìn)，為藥企“原料+制劑”一體化戰(zhàn)略貢獻(xiàn)力量。 公司獲授權(quán)發(fā)明專利3項(xiàng)，申請專利8項(xiàng)，其中ICP申請２項(xiàng)。 Beijing Ruqueen Biotech.，Co., Ltd.?is a high-tech enterprise integrating the R&D and business promotion of novel food ingredients, APIs and intermediates, and novel pharmaceutical excipients. The company advocates a green, eco-friendly, and differentiated approach to health and wellness, emphasizing RSM(Regulatory Starting Material) research and QbD (Quality by Design) process development to ensure economical, environmentally friendly, safe, and quality-controllable manufacturing processes. The company operates a?1,000+ square meter R&D center?in the Beijing Economic-Technological Development Area (BDA), housing departments for process development, pilot-scale conversion, commercial production, quality research, and business promotion. The center's team comprises?Ph.D. and M.S. holders in chemistry?with over 20 years of commercial production experience in APIs. It is equipped with multiple advanced instruments including: 50/100L glass reactors, 20L rotary evaporators, HPLC, IR, LC-MS, GC-MS. Additionally, the company maintains?stable cooperative manufacturing bases?in Tianjin City, Hebei Province, Shandong Province, Inner Mongolia Autonomous Region, and other regions, enabling scaled commercial production. The company conducts R&D and commercial manufacturing of: Complex active pharmaceutical ingredients (APIs), Pharmaceutical intermediates, Novel food ingredients and Advanced pharmaceutical excipients The company provides comprehensive services including: ? Registration filing support for APIs/excipients (e.g., DMF/CEP preparation) ? Process optimization for existing pharmaceutical materials ? Enabling "API + Formulation" integration strategies for pharmaceutical partners Intellectual Property Achievements: ? 3 authorized invention patents ? 8 pending patent applications (including 2 PCT international filings)