Polyethylene Oxide (PEO), Benzalkonium Chloride (BKC) and Injectable-Grade Trehalose Dihydrate — from a China-based manufacturer with Excipact GMP certification, NMPA registration, China DMF support and a complete, QA-ready document pack.
聚环氧乙烷（PEO）、苯扎氯铵（BKC）、注射级海藻糖二水合物 —— 中国本土生产，具备 Excipact GMP 认证、 NMPA 注册与 DMF 支持，并配有可直接递交 QA 的完整资料包。
Every grade ships with a CoA, batch-to-batch consistency data and a compendial compliance statement. Pick a product to see the full specification, the grade-matching table and the documents available.
每个规格随货提供 CoA、批间一致性数据与药典符合性声明。点击产品可查看完整规格、型号对标表与可提供的文件清单。
Hydrophilic matrix and push-layer polymer for ER tablets and push-pull osmotic pumps.
用于缓释片亲水骨架与渗透泵推动层的高分子材料。
Broad-spectrum antimicrobial preservative for multi-dose ophthalmic, nasal and otic formulations.
广谱抑菌剂，用于多剂量滴眼剂、鼻喷剂与滴耳剂。
Non-reducing disaccharide lyoprotectant for mAbs, proteins and cell-based biologics.
非还原性二糖冻干保护剂，用于单抗、蛋白与细胞类生物制品。
Switching an excipient supplier normally means re-validation, re-filing and a QA review queue. We built the offer around removing exactly those three things.
更换辅料供应商通常意味着重新验证、重新备案与漫长的 QA 审核排期。我们的方案就是针对这三件事设计的。
Grades are benchmarked against Dow WSR® and Sumitomo PEO, the Novo Nordisk-grade BKC position and Nagase Viita / Pfanstiehl / BioSpectra trehalose. Existing formulations transfer without reformulation.
型号对标 Dow WSR® 与住友 PEO、诺和诺德级别 BKC、以及 Nagase Viita / Pfanstiehl / BioSpectra 海藻糖。现有处方可直接切换，无需重新配方。
A QA reviewer's first question is never "how much", it is "is the pack complete". One index page, thirteen documents, sent as links with your first email.
药厂 QA 拿到邮件后，第一反应不是「价格多少」，而是「文件全不全」。一页索引 + 十三份文件，随首封邮件以链接形式给出。
Excipact GMP certificate issued by SGS, NMPA registration and China DMF filing. A written supplier questionnaire covers most excipient cases — on-site audit whenever your procedure requires it.
SGS 签发的 Excipact GMP 证书、NMPA 注册与中国 DMF 备案。辅料在多数情况下可用书面供应商问卷替代现场审计；若贵司流程要求现场审计，我们随时安排。
No.1 Chinese local supplier position for PEO, with batch-to-batch consistency data as standard. You are adding a manufacturer's channel, not a reseller.
PEO 在中国本土市场占有率第一，批间一致性数据为标准交付项。你增加的是生产商渠道，不是转手贸易商。
The pack is organised the way a regulatory reviewer reads it: quality system first, then safety statements, impurity control, product data, regulatory filings and regional add-ons.
资料包按法规审评人员的阅读顺序组织：质量体系 → 安全性声明 → 杂质控制 → 产品数据 → 法规文件 → 区域附加。
We will come back with the matching grade, the relevant documents and a sample plan. First reply is normally within one working day.
我们会回复匹配的型号、对应文件与样品方案。通常一个工作日内首次回复。
