Sacubitril Valsartan Sodium (LCZ696), the first Angiotensin Receptor Neprilysin Inhibitor (ARNI), has reshaped the treatment paradigm for heart failure and hypertension. Unlike conventional therapies, LCZ696 works through a dual mechanism—combining Sacubitril (a neprilysin inhibitor) with Valsartan (an angiotensin receptor blocker) in a stable co-crystal form.
However, its complex molecular structure requires highly specialized expertise in synthesis, chiral control, and regulatory compliance. At Huzhou Ureda Pharmaceutical Co., Ltd., we provide a secure, GMP-compliant, and technically advanced supply chain covering LCZ696, Sacubitril API (AHU-377), and critical chiral intermediates.
Our Product Portfolio: From Intermediates to API
We offer a full spectrum of Sacubitril-related materials, enabling seamless support from R&D projects to commercial manufacturing.
| Product Name | CAS Number | Role & Significance |
|---|---|---|
| Sacubitril Valsartan Sodium (LCZ696) | 936623-90-4 | Finished API in co-crystal form, used directly in formulations |
| Sacubitril hemicalcium salt (AHU-377) | 1369773-39-6 | Active Pharmaceutical Ingredient (API), metabolized to Sacubitril |
| Sacubitril Sodium | 149690-05-1 | API salt form, suitable for multiple dosage forms |
| (2R,4S)-4-Amino-5-(biphenyl-4-yl)-2-methylpentanoic Acid Ethyl Ester HCl | 149690-12-0 | Key chiral intermediate establishing the (2R,4S) stereochemistry |
| Boc-Protected intermediates (e.g. CAS 1012341-50-2) | 1012341-50-2 | Advanced synthetic building blocks ensuring amino protection |
Technical Expertise: Chiral Synthesis & Process Mastery
The therapeutic efficacy of Sacubitril is entirely dependent on its (2R,4S) stereochemistry. Ureda Pharm employs a finely tuned synthetic route with strict stereochemical control:
-
Starting Material: N-[(1R)-2-[1,1′-Biphenyl]-4-yl-1-(hydroxymethyl)ethyl]carbamic acid tert-butyl ester (CAS: 1426129-50-1).
-
Wittig Reaction: Using Ethyl 2-(triphenylphosphoranylidene)propionate (CAS: 5717-37-3), we construct the highly selective (R,E)-olefin intermediate (CAS: 1012341-48-8).
-
Chiral Construction: Boc-protection ensures stability during multi-step synthesis, leading to Boc-protected amino acids (CAS: 1012341-50-2).
-
Deprotection & Final Steps: Yielding the pharmacophoric core (CAS: 149690-12-0), followed by synthesis into Sacubitril Sodium, AHU-377, and finally LCZ696.
🔬 Analytical Excellence: We employ chiral HPLC and advanced analytical methods to guarantee enantiomeric excess (e.e.) >99.5%, ensuring consistent efficacy and safety.
Why Ureda Pharm? Our Core Advantages
1. Superior Process & Quality Control
-
Guaranteed Chiral Purity: Continuous monitoring ensures >99.5% e.e. for all key intermediates.
-
Impurity Research: Comprehensive studies on Genotoxic Impurities (GTIs) aligned with ICH guidelines.
-
Strict QC Standards: Our internal standards exceed pharmacopeia requirements, with full COA documentation.
2. Regulatory & Documentation Support
-
Compliance with cGMP and ICH Q7 requirements.
-
DMF-ready documentation and technical transfer support for global regulatory submissions (US, EU, etc.).
3. Stable & Flexible Supply Chain
-
Vertical Integration: In-house production of intermediates ensures price stability and supply security.
-
Scalable Manufacturing: From kilograms to ton-scale, suitable for clinical trials and commercial launches.
Applications & Customer Support
We support clients across the full development cycle:
-
Generic Drug Development: APIs with regulatory support for ANDA filings.
-
New Dosage Forms: Customization for polymorphs and particle size.
-
Process Validation: GMP-compliant validation batches and documentation.
Our end-to-end services—from technical consultation and sample provision to regulatory submission support—make us the trusted partner of choice in cardiovascular APIs.
Conclusion: Partner with Ureda Pharm
The future of cardiovascular disease treatment relies on precision, reliability, and compliance. With deep expertise in chiral synthesis, robust quality systems, and a stable global supply chain, Huzhou Ureda Pharmaceutical Co., Ltd. is uniquely positioned to support your projects in Sacubitril Valsartan Sodium and its intermediates.
📩 Contact us today for professional consultation or free samples.
Contact Information
Owen Lee
Huzhou Ureda Pharmaceutical Co., Ltd.
📞 Phone / WhatsApp: +86-13867276965
💬 WeChat: 18270717590
🌐 Website: www.uredapharm.com
📧 Email: salesowenlee@gmail.com
