Semaglutide API and Research Peptide Supplier

What is Semaglutide API?

Semaglutide is a long-acting GLP-1 (glucagon-like peptide-1) receptor agonist: a 31-amino-acid peptide based on the human GLP-1(7-37) backbone, structurally modified for extended half-life. Two substitutions (Aib at position 8 and Arg at position 34) plus acylation with a C18 fatty di-acid attached through a γGlu-2×OEG linker give the molecule strong albumin binding, resistance to DPP-4 degradation and an extended half-life.

As an active pharmaceutical ingredient (API), semaglutide (CAS 910463-68-2, molecular formula C187H291N45O59, ~4113.58 g/mol) is supplied as a lyophilised powder for formulation into finished pharmaceutical products. It is one of the highest-demand peptide APIs globally, driven by its use in type 2 diabetes and chronic weight-management therapies. Winhycare Pharma supplies this API strictly on a B2B basis to licensed pharmaceutical manufacturers, formulation developers and research organisations.

Winhycare Pharma as your Semaglutide API supplier

Semaglutide is a synthetically challenging acylated peptide: the lipid side-chain conjugation, the Aib residue and the 31-mer length all create opportunities for deletion sequences, diastereomers and incomplete acylation. Winhycare Pharma supplies semaglutide produced to demanding standards, by optimised Fmoc solid-phase peptide synthesis (SPPS) with controlled side-chain conjugation, then purified on preparative dynamic axial compression (DAC) HPLC columns to isolate the target sequence sharply from closely related impurities.

The material is sourced to a specification that ensures repeatable batch-to-batch consistency from optimisation runs through kilogram and multi-kilogram commercial campaigns, with lyophilisation to a stable, uniform API powder. As a CRDMO sourcing partner we also coordinate process development, technology transfer and scale-up support so customers can move from clinical to commercial supply through a single, audit-ready source.

Quality specifications & impurity control

Each batch is released against a defined specification with a Certificate of Analysis (COA). Purity is determined by UPLC/HPLC and the sequence and minor structural variants are confirmed by LC-MS impurity profiling. Our target release purity is ≥99.0%, with individual impurities controlled strictly below 0.10%, supported by ICH Q1A(R2) long-term and accelerated stability data.

Full traceability is maintained from raw materials and resins through to final batch-release records. Analytical methods are validated to ICH Q2(R1), and water content, acetate/counter-ion content, residual solvents and peptide content are characterised so the API is ready for regulated formulation development.

Regulatory & documentation support (US-DMF / CTD Module 3)

Winhycare Pharma provides the documentation customers need to file with their own submissions and to streamline global regulatory review. For semaglutide we support US-DMF Type II dossiers, CTD Module 3 CMC sections (for IND/NDA/ANDA referencing), analytical validation packages to ICH Q2(R1), and stability data with SOP access.

A dedicated B2B support desk helps resolve deficiency letters, regulator information requests and customer QA queries during filing. The supplied material is backed by quality systems built around pre-approval-inspection (PAI) readiness aligned to FDA, EMA and PMDA expectations, reducing review cycles and supporting faster approval of the customer's finished product.

Packaging, cold-chain export & custom synthesis

Semaglutide API is packaged under controlled, low-temperature conditions and shipped via validated cold-chain logistics with active temperature monitoring and customs documentation for the US, Europe and Asia. Standing supply agreements, safety-stock reserves and flexible delivery scheduling keep customer production lines running.

Beyond catalogue supply, we offer custom synthesis and made-to-order quantities (including isotope-free reference standards, specified salt forms and tailored purity grades) to match exact client requirements. Quotations, COA, and regulatory documentation are provided on request; minimum order quantities are agreed per programme.

Research supply from Winhycare Pharma

Winhycare Pharma supplies research-grade Semaglutide to research organisations and individual researchers for research and development purposes. Material is supplied at high purity (>99%) under stringent quality control with QC documentation, in secure packaging through global standard logistics, with dedicated technical assistance from our team. We focus on consistent quality and purity, reliable and timely supply, confidential and professional service, and long-term partnerships.

Research use only. Not for human or veterinary use, and not for use in food, drugs, medical devices or cosmetics.

To enquire, tell us the quantity you need, the purity grade, the documentation you require and the destination country. The buyer is responsible for complying with the import and use regulations that apply to Semaglutide in their country.