Winhycare Pharma · Peptide APIs
Peptide API supplier from India
Winhycare Pharma supplies five peptide APIs: Semaglutide, Tirzepatide, Retatrutide, Cagrilintide and BPC-157. We supply them B2B to licensed pharmaceutical manufacturers and developers in Europe, the USA and worldwide. Every batch comes with a Certificate of Analysis, and semaglutide is supported with US-DMF Type II and CTD Module 3 documentation.
Reviewed by Kareem Ahmed Basha, Director & Chief Scientific Officer · Updated
- 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
The five peptide APIs we supply
Each molecule has its own page with the specification, production route, regulatory status and documentation.
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| API | CAS number | Drug class | Regulatory status | Documents |
|---|---|---|---|---|
| Semaglutide API | 910463-68-2 | GLP-1 receptor agonist (acylated 31-amino-acid peptide) | Approved active ingredient (FDA, EMA) | COA; US-DMF Type II and CTD Module 3 support |
| Tirzepatide API | 2023788-19-2 | GIP / GLP-1 dual receptor agonist | Approved active ingredient (FDA, EMA) | COA; further documents confirmed per programme |
| Retatrutide API | 2381089-83-2 | GLP-1 / GIP / glucagon triple receptor agonist | Investigational (Phase 3), not approved | COA; further documents confirmed per programme |
| Cagrilintide API | 1415456-99-3 | long-acting amylin analogue | Investigational, not approved | COA; further documents confirmed per programme |
| BPC-157 API | 137525-51-0 | pentadecapeptide (body-protection compound) | Not approved; FDA compounding Category 2 (2023) | COA; further documents confirmed per programme |
What is a peptide API?
An active pharmaceutical ingredient (API), also called the drug substance, is the component of a medicine that produces its effect. A peptide API is a chain of amino acids made to a defined specification, most often by solid-phase peptide synthesis (SPPS), liquid-phase synthesis (LPPS), a hybrid of the two or recombinant expression, then purified by preparative HPLC and lyophilised to a powder.
API manufacture follows GMP for active substances, set out internationally in ICH Q7. In the EU, an API imported from outside the EEA also needs a written confirmation from the exporting country; in the US, the API is usually referenced through a Type II Drug Master File. Our guide what is a peptide API covers this in detail.
API grade or research grade
The rules follow the end use, not the type of buyer. Tell us the end use in your first enquiry so we quote the right grade and documents.
API grade
- For medicines and clinical-trial products
- Supplied B2B to licensed manufacturers and developers
- COA plus the regulatory documents your market requires
Research grade (RUO)
- For laboratory research only, not for human or veterinary use
- >99% purity with QC documentation
- Cannot later become the API of a medicinal product
Who buys peptide APIs from us
- Pharmaceutical manufacturers and generic developersAPI for a finished product and the development batches behind the application.
- Biotech and drug-development companiesAPI for investigational products and clinical programmes.
- CDMOs, CMOs and fill-finish companiesAPI sourced for a client’s product, or a client’s API taken into vials.
- Research organisationsResearch-grade peptides for laboratory work, supplied separately as research use only.
How API supply works
- 1 EnquiryTell us the molecule, grade, quantity, destination market and the documents your quality and regulatory teams need.
- 2 Specification and documentsWe confirm the specification, the Certificate of Analysis and which regulatory documents are available for that molecule and market.
- 3 Supplier qualificationYour QA reviews the COA and documentation and runs its questionnaire or audit, as your procedures require.
- 4 SupplyQuantities, delivery schedule and shipping conditions are agreed per programme, from development batches to commercial volumes.
From API to lyophilised vials
If you need the API in vials, we lyophilise and fill peptides and biosimilars at WHO-GMP certified manufacturing partners in India, from cycle development through engineering, pilot and commercial batches. The service is also available on its own: you can bring your own peptide. See peptide lyophilisation and vial filling.
Buyer guides
Regulatory and technical reading for teams qualifying an Indian peptide API source, with the primary sources linked.
- Peptide API supplier for Europe, the UK and SwitzerlandWritten confirmation, EU GMP Part II, ASMF and CEP routes, and the QP declaration.
- Peptide API supplier for the USAType II DMF, GDUFA completeness assessment, ICH Q7 and FDA establishment registration.
- What is a peptide API?API versus drug substance, and how peptide APIs are made and regulated.
- 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.
- How to read a semaglutide API certificate of analysisWhat each line of a semaglutide COA tells your QA team.
- Semaglutide patent expiry by countryWhere generic semaglutide can launch, and when.
- SPPS vs LPPSSolid-phase and liquid-phase peptide synthesis compared.
Peptide APIs: frequently asked questions
Which peptide APIs does Winhycare Pharma supply?
Five: Semaglutide, Tirzepatide, Retatrutide, Cagrilintide and BPC-157. They are supplied B2B to licensed pharmaceutical manufacturers and developers in Europe, the USA and worldwide, each with a Certificate of Analysis.
Is Winhycare Pharma a peptide API manufacturer?
Winhycare Pharma is a peptide API supplier and CRDMO sourcing partner based in Hyderabad, India. The APIs we supply are sourced to a defined specification, and we coordinate the documentation, supplier qualification and supply for each programme.
Which documents come with a peptide API?
Every batch ships with a Certificate of Analysis. For semaglutide we support US-DMF Type II dossiers and CTD Module 3 documentation. For the other APIs, which regulatory documents are available for a given molecule and market is confirmed during supplier qualification.
How much does a peptide API cost?
There is no public price list. The price depends on the molecule, the quantity, the purity specification, the documentation package and the packaging. Send your specification and target volume and we quote for that programme.
What is the minimum order quantity?
Minimum order quantity and lead time are agreed per programme, depending on the grade, quantity and documentation scope.
Can you supply GLP-1 APIs for generic development?
Yes, to licensed pharmaceutical manufacturers and developers. Patent and regulatory-exclusivity status differs by country, so check your target markets before development; our semaglutide patent-expiry guide sets out the main dates.
What is the difference between API grade and research grade?
API grade is for medicines and clinical-trial products and has to come with the GMP and regulatory documentation your market requires. Research grade is for laboratory research only, not for human or veterinary use, and cannot later become the API of a medicinal product. Tell us the end use in your enquiry so we quote the right grade.
Can you also lyophilise and fill the API into vials?
Yes. Lyophilisation and vial filling of peptides and biosimilars are carried out at WHO-GMP certified manufacturing partners in India, and you can also bring your own peptide for the service on its own.
Source a peptide API from Winhycare Pharma
Send the molecule, quantity, destination market and documents you need. We reply with pricing, a Certificate of Analysis and the documentation available for your filing.
More from Winhycare Pharma · Peptide APIs
Products & services
- Peptide APIs & CMO services
- Peptide API supplier (5 APIs)
- Semaglutide API supplier
- Tirzepatide API supplier
- Research peptides (RUO), >99% purity
- GLP-1 research peptides
- Custom peptide synthesis
- Peptide lyophilisation (lyophilization) services
- Biosimilar and protein lyophilisation
- Lyophilisation for European companies
- Peptide CDMO & contract manufacturing
- Peptide API supplier for Europe
- Peptide API supplier for the USA
Guides
