API R&D Platform

Internationalized API↓∑ $ (including related intermediate₽α‌s) R&D and registration p≥≥↕latform. The R&D team is familiar w↓λith drug registration regulati✔β₹ons and chemical dru✘←‍g R&D technical g±λ±uidelines in various countries, and hasφ∞ rich experience in submiφ≤♦tting DMF registration applicatioβ★★ ns for APIs in CDE, FDA, and EDQM​$✔, as well as supplementary res☆ earch and response baseγ♦™↓d on expert review opinions, and has φ®accepted research and developme™γ£nt many times and the inspe>✔"ction of the production site.β♥

The professional team asses∑™®ses whether the R&D project has in♣ ↓£fringement risks, proposes straΩ₹¥εtegies to avoid patent risks, explorπ€↕∞es the patentability of R&D pr♠ ≠™ojects and applies for patents.

The synthesis team has the abilit♥δ↑≥y and large-scale pro☆☆ →duction experience for the₹εα process development, process optimi≥‌↓zation and process conversio↑↔"σn of a variety of difficβ±ult products, especially APIs and in♣÷→termediates in the multi-chiral centerΩ‍. It can quickly ope♣→β¥n up routes, optimize§ ₩ the process while taking into accou∑>÷nt cost control and e♣÷nvironmental protection rγ δequirements, and the factory conver≤★sion efficiency is high∏λ ‍.

The team is familiar with the☆€ quality research of various APIs, and ©♠$has rich research experience on δ☆the purity, content,π‍₩ impurities, isomers•δΩ, crystal form, crystal habit, particl∞÷e size, and fluidity of APIs.

Good at reaction types includ>¥‌$e hydrogenation, asymmetric catalysis,  →÷σlow temperature reaction, Gr✘§∞ ignard reaction, etc.

It can provide customized synthesis s♣‌₩ervices of gram-level to∞β±♦ ton-level products ♥©≠of various small molecule new✘÷← drug compounds.

The company has more than 400 sets ↓☆ of various synthesis,✔β₩ preparation, and ana∏₹≈≤lysis equipment, and has a compl≥εete set of synthesis, pre →<paration pilot/pilot research and de$₩∏velopment equipment, including r♦✔Ω¥otary evaporator, glass reactor,>β¶ liquid phase preparation, fluidized ←☆≠₩bed, and granulator , Tablet press♥☆λ☆, coating machine, capsule filling m₽₽>★achine, freeze dryer, etc.;'÷™γ various analysis and tesβ≤¶✔ting equipment, includiπ←ng LC-MS, HPLC, UPLC, GC, TG←↕≥A, DSC, etc.