GLP-1 & Incretin Multi-Agonists · Peptide API · research grade also available
Semaglutide API Supplier from India
CAS 910463-68-2 · 4113.58 g/mol · COA with every batch
Semaglutide (CAS 910463-68-2) is a 31-amino-acid acylated GLP-1 receptor agonist and an approved active ingredient. Winhycare Pharma supplies it as an API to licensed pharmaceutical manufacturers and, separately, as a research-grade peptide for laboratory research use only, at >99% purity with QC documentation. Research-grade material is not for human or veterinary use.
By Kareem Ahmed Basha, Director & Chief Scientific Officer · Reviewed by Nisar Mohammed, Founder & Managing Director · Updated
Need research-grade Semaglutide for laboratory work? Request a research quote (research use only). See all five peptide APIs.
- COA with every batchReleased against a defined specification
- Filing documentsConfirmed per molecule and market
- B2B onlyLicensed manufacturers and developers
- EU, UK, USA, worldwideBuyer guides for each market
- Lyophilisation & fillingAt WHO-GMP certified partners
- CAS Number
- 910463-68-2
- Molecular Formula
- C187H291N45O59
- Molecular Weight
- 4113.58 g/mol
- Drug Class
- GLP-1 receptor agonist (acylated 31-amino-acid peptide)
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.
Research-grade material: research use only. Research-grade Semaglutide is supplied for laboratory research only, not for human or veterinary use; API-grade material for pharmaceutical manufacturers is quoted separately with its documentation. We do not provide dosing or usage advice. Approved as an active ingredient by major regulators including the US FDA and EMA for type 2 diabetes and chronic weight management.
Semaglutide API: Specifications
| Compound | Semaglutide |
|---|---|
| CAS Number | 910463-68-2 |
| Molecular Formula | C187H291N45O59 |
| Molecular Weight | 4113.58 g/mol |
| Sequence | 31 amino acids, acylated (C18 di-acid side chain) |
| Drug Class | GLP-1 receptor agonist |
| Appearance | White to off-white lyophilised powder |
| API purity (HPLC) | ≥ 99.0% (single impurity < 0.10%) |
| Synthesis | Fmoc SPPS + DAC prep-HPLC purification |
| Documentation | COA, US-DMF Type II, CTD Module 3 support |
| Storage | Store at -20°C, protected from light & moisture |
| API use | B2B: licensed pharmaceutical manufacturing & R&D |
| Purity | >99% (research grade) |
| Intended use | Research grade: research use only (RUO); API: licensed manufacturing |
API supplied for B2B pharmaceutical manufacturing and R&D. Semaglutide is also supplied for research use only, not for human or veterinary use. Regulatory status: Approved as an active ingredient by major regulators including the US FDA and EMA for type 2 diabetes and chronic weight management.
Research guides
Articles in the Peptide Research Library that cover Semaglutide.
- Semaglutide: research overviewSemaglutide is a 31-amino-acid analogue of human GLP-1(7–37) that activates the GLP-1 receptor. An Aib substitution at position 8 blocks DPP-4 cleavage, and a C18 fatty di-acid on lysine 26 binds albumin, giving an elimination half-life of about one week. Phase 3 programmes (SUSTAIN, PIONEER, STEP, SELECT) underpin its approvals.
- Amycretin: what it is, how it works and what studies have foundAmycretin, now named zenagamtide, is a 68-amino-acid single peptide that activates GLP-1 receptors and amylin and calcitonin receptors. It has been tested as a weekly subcutaneous and a daily oral form in phase 1 and phase 2 trials, and entered phase 3 (AMAZE and AMBITION) in 2026. It is not approved anywhere.
- Cagrilintide: what it is, how it works and what studies have foundCagrilintide is an investigational long-acting analogue of the pancreatic hormone amylin. It is a 37-amino-acid peptide with a Cys2–Cys7 disulfide bridge, three substitutions versus pramlintide and a C20 fatty di-acid on its N-terminus, and it activates both amylin and calcitonin receptors. Its half-life is 159–195 hours.
- What is a drug master file? DMF, ASMF and CEP for a peptide API, with the CTD Module 3 sectionsDMF stands for drug master file: a confidential submission to FDA describing how a drug substance, packaging or excipient is made and controlled. A peptide API maker files a Type II DMF in CTD Module 3 format and authorises customers to reference it by letter. FDA does not approve DMFs; it reviews them with the applications that cite them.
- FDA-approved peptide drugs: a list by INN, approval year, target and lengthReviews published in 2021 and 2022 put the number of peptide drugs approved worldwide at more than 80. The tables below list 55 FDA-approved peptides by INN, from oxytocin and glucagon to the 2026 approvals rusfertide, icotrokinra, enlicitide and navepegritide, with first Drugs@FDA approval year, target and length. Data cut-off: 26 October 2026.
- Generic semaglutide: EU and US regulatory pathways, and what API makers must showHow generic semaglutide is filed in the EU and US: generic vs hybrid, 8+2+1 protection, ANDA vs 505(b)(2), synthetic vs recombinant API, API maker duties.
- GLP-1 receptor agonists explained: how they work, the full list, and where research is headingGLP-1 receptor agonists are peptides, and now one small molecule, that activate the receptor for the gut hormone glucagon-like peptide-1. The receptor raises cAMP in beta cells, increasing insulin secretion only when glucose is high, while also suppressing glucagon, slowing gastric emptying and reducing food intake. Dual and triple agonists add GIP or glucagon receptor activity.
- GMP peptides explained: what GMP grade means, GLP vs GMP, and research grade vs GMP gradeA GMP grade peptide is one manufactured and released under good manufacturing practice for active pharmaceutical ingredients, set out internationally in ICH Q7: an independent quality unit, batch records, validated processes, change control and a batch Certificate of Analysis. Research grade describes intended laboratory use, not a regulated standard. GLP governs nonclinical safety studies, not manufacture.
- How to read a peptide COA: every test explained, red flags and how to verify itA peptide COA should be specific to your batch and list each test with its method, acceptance limit and numerical result: identity by mass spectrometry, HPLC purity with the chromatogram, peptide content, water, counter-ion, residual solvents and, where relevant, endotoxin. Verify it by matching the lot number, identifying the laboratory and checking its accreditation.
- HPLC method validation under ICH Q2(R2) and Q14: a practical guide for peptide purity and assay methodsICH Q2(R2), adopted on 1 November 2023 and in effect in the EU since 14 June 2024, sets how an HPLC method is shown fit for purpose. A peptide purity or assay method is validated for specificity, reportable range and response, accuracy, precision and, for impurities, quantitation limit, with robustness studied during development under ICH Q14.
- What is ICH Q11? Starting materials, control strategy and Q6A/Q6B specifications for peptide drug substancesICH Q11 is the ICH guideline on developing and manufacturing drug substances, adopted on 1 May 2012. It covers process development, starting material selection, control strategy and how this is presented in CTD sections 3.2.S.2.2–3.2.S.2.6. ICH Q6A and Q6B cover specifications, but only partly fit synthetic peptides, so EMA's 2025 peptide guideline fills the gaps.
- ICH Q7 explained: GMP for active pharmaceutical ingredients, chapter by chapter, with peptide APIs in focusICH Q7 is the international good manufacturing practice guide for active pharmaceutical ingredients, adopted at Step 4 on 10 November 2000. Its 20 chapters cover quality management, facilities, documentation, materials, production, laboratory controls, validation, change control and clinical-trial APIs. FDA, the EU and PIC/S inspectorates use it as the GMP standard for API manufacturers.
- Peptide modifications for stability and half-life: lipidation, PEGylation, Aib, cyclisation and fusionNative peptides are cleared in minutes. Modifications fix that in two ways: blocking proteolysis, with non-natural residues such as Aib, D-amino acids, cyclisation and terminal capping; and slowing renal clearance, with fatty acid acylation or PEGylation that enlarge the molecule or bind it to albumin.
- Peptide synthesis: how peptides are made, from the first resin bead to a purified kilogramPeptide synthesis builds a chain of amino acids in a controlled order. Most peptides are made by solid-phase peptide synthesis (SPPS), where the chain grows on a resin through repeated deprotection and coupling cycles, then is cleaved, purified by preparative chromatography and isolated, usually by lyophilization.
- Retatrutide: what it is, how it works and what studies have foundRetatrutide (LY3437943) is an investigational 39-amino-acid peptide that activates the GIP, GLP-1 and glucagon receptors. It carries Aib at positions 2 and 20, α-methyl-leucine at 13 and a C20 fatty di-acid on lysine 17, giving a half-life of about 6 days. Phase 3 TRIUMPH results were published in 2026; it is not approved anywhere.
- How to read a semaglutide API certificate of analysis (COA)A test-by-test guide to a semaglutide API COA: identity, assay, purity, peptide content, water, acetate, residual solvents, endotoxin and the specs behind them.
- Semaglutide patent expiry by country: dates, status and what it means for API buyersWhen semaglutide's compound protection ends in India, China, Canada, Brazil, the US, EU, UK and Japan, with primary sources, and what it means for API buyers.
- Semaglutide vs tirzepatide vs liraglutide: how the three peptide APIs compareHow semaglutide, tirzepatide and liraglutide APIs differ: backbone, length, lipid chain, receptors, half-life basis, molecular weight, CAS and approval.
- Tirzepatide: what it is, how it works and what studies have foundTirzepatide is a 39-amino-acid peptide based on the GIP sequence that activates both the GIP and GLP-1 receptors. Two Aib residues resist DPP-4, and a C20 fatty di-acid on lysine 20 binds albumin, giving an elimination half-life of about 5 days. The SURPASS and SURMOUNT phase 3 programmes support its approvals.
- What is a peptide? Definition, types, functions and how peptides are madeA peptide is a chain of amino acids joined by amide links called peptide bonds. IUPAC calls chains of fewer than about 10 to 20 residues oligopeptides and longer chains polypeptides. Many hormones, such as oxytocin and GLP-1, are peptides, and more than 80 peptide drugs have reached the market.
Buyer guides
Regulatory and technical reading for teams qualifying an Indian peptide API source.
- All five peptide APIs we supplySemaglutide, tirzepatide, retatrutide, cagrilintide and BPC-157 compared: CAS, status and documents.
- Sourcing peptide API for the EU, UK and SwitzerlandWritten confirmation, EU GMP Part II, ASMF / CEP and the QP declaration.
- Sourcing peptide API for the United StatesType II DMF, ICH Q7, FDA’s July 2026 peptide guidance changes and establishment registration.
- Semaglutide patent expiry by countryWhere generic semaglutide can launch, and when.
- How to qualify a peptide API supplierA documentation and audit checklist for EU and US buyers.
- Peptide API impurities and specificationsRelated substances, thresholds and pharmacopoeial context.
- Peptide lyophilisation CMO servicesFrom your peptide API to lyophilised vials, starting with a pilot.
Semaglutide API: Frequently Asked Questions
What is the CAS number and molecular weight of Semaglutide?
Semaglutide's CAS number is 910463-68-2, its molecular formula is C187H291N45O59, and its molecular weight is approximately 4113.58 g/mol. It is a 31-amino-acid GLP-1 receptor agonist acylated with a C18 fatty di-acid side chain.
What is the amino acid sequence of semaglutide?
H-His-Aib-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys(γGlu-2×OEG-C18 di-acid)-Glu-Phe-Ile-Ala-Trp-Leu-Val-Arg-Gly-Arg-Gly-OH. It is the human GLP-1(7-37) sequence with Aib at position 8, Arg at position 34, and the lysine at position 26 acylated with a C18 fatty di-acid through a γGlu-2×OEG linker.
Who supplies semaglutide API in India?
Several Indian companies make or supply semaglutide API. Winhycare Pharma, based in Hyderabad, supplies semaglutide API B2B to licensed pharmaceutical manufacturers in Europe, the USA and worldwide, with a Certificate of Analysis for every batch and US-DMF Type II and CTD Module 3 documentation support.
What purity grade does Winhycare Pharma's Semaglutide API meet?
Our target release purity is ≥99.0% by UPLC/HPLC, with individual impurities controlled below 0.10%, confirmed by LC-MS impurity profiling and supported by ICH stability data. Each batch ships with a Certificate of Analysis.
Do you provide US-DMF and CTD Module 3 support for Semaglutide?
Yes. We support US-DMF Type II dossiers and CTD Module 3 CMC documentation, plus ICH Q2(R1) analytical validation packages and stability data, to help customers file IND/NDA/ANDA submissions and streamline regulatory review.
How is Semaglutide API produced?
It is produced by optimised Fmoc solid-phase peptide synthesis (SPPS) with controlled lipid side-chain conjugation, followed by preparative dynamic axial compression (DAC) HPLC purification and lyophilisation to a stable powder, in kilogram to multi-kilogram campaigns. Winhycare Pharma supplies material meeting these standards.
What is the minimum order quantity and lead time?
Minimum order quantity and lead time are agreed per programme depending on grade, quantity and documentation scope. Share your specification and target volume and our team will confirm pricing, MOQ and a delivery schedule.
Can Winhycare Pharma supply Semaglutide as a reference standard or custom grade?
Yes. Beyond standard API supply we provide custom synthesis, specified salt forms, tailored purity grades and reference-standard quantities to match exact client requirements.
How is Semaglutide API shipped and stored?
It is supplied as a lyophilised powder, stored at -20°C protected from light and moisture, and shipped via validated cold-chain logistics with active temperature monitoring and customs documentation for the US, Europe and Asia.
Who can buy Semaglutide from Winhycare Pharma?
Semaglutide API for pharmaceutical manufacturing is supplied B2B to licensed pharmaceutical manufacturers and formulation developers. Research-grade semaglutide is supplied separately to research organisations and individual researchers for research use only, not for human or veterinary use.
Is Semaglutide sold for human use?
No. Research-grade semaglutide is supplied for research use only (RUO) and is not for human or veterinary use, or for use in food, drugs, medical devices or cosmetics. Semaglutide API for regulated pharmaceutical manufacturing is supplied separately, B2B, to licensed pharmaceutical manufacturers.
What purity is research-grade Semaglutide supplied at?
Research-grade Semaglutide is supplied at high purity (>99%), produced under stringent quality control and accompanied by QC documentation. State any specific purity or documentation requirement in your enquiry.
How do I order Semaglutide for research?
Send an enquiry with the quantity, purity, documentation you need and the destination country, and our team will reply with dedicated technical assistance. The buyer is responsible for complying with the import and use regulations for Semaglutide in their country.
How much does Semaglutide API cost?
There is no public price list for Semaglutide API. The price depends on the quantity, the purity specification, the documentation package and the packaging, so we quote per programme. Send your specification and target volume to receive pricing and a Certificate of Analysis.
Sources
- Semaglutide: substance record, CAS Common Chemistry
- Semaglutide: compound record, PubChem, NCBI
- Semaglutide: drug entry, DrugBank
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Source Semaglutide API from Winhycare Pharma
Request pricing, a Certificate of Analysis and the regulatory documentation support your filing needs (US-DMF / CTD Module 3). Custom synthesis and bulk quantities available.