There is a meaningful gap between a research peptide and a pharmaceutical peptide active ingredient, and it is a documentation gap more than a chemistry gap. The molecule can be identical; what changes is whether the batch records, analytical methods, specifications and stability data are controlled well enough to support a regulatory filing and to survive an audit.
Who this is for
- Pharmaceutical manufacturers requiring bulk active ingredient for formulation or clinical supply
- Compounding pharmacies and hospital formularies operating to recognised standards
- Clinical trial material supply, where the material needs to reach the investigator site under a defined specification
- Distributors building a regional stock position with a compliant document trail
If you are buying single vials for a laboratory, you do not need this page — the catalogue and our lab-testing service are the relevant routes.
Documentation for API supply
| Document | What it supports |
|---|---|
| Certificate of Analysis | Batch release against a stated specification, with the underlying chromatogram |
| DMF-compatible batch records | Reference in a regulatory filing — manufacturing records, analytical method validation, specifications |
| Stability data | Retest and shelf-life justification at the declared storage condition |
| Residual solvent analysis | ICH Q3C conformance for the synthesis route used |
| Endotoxin | Where the application requires it |
| Certificate of Origin | Destination customs and any preferential duty claim |
| MSDS | Handling and transport |
Full detail on the pack is on our export documentation page.
Scale and presentation
API supply is generally from 100 mg to multi-kilogram, depending on sequence and programme. Presentation is bulk powder in sealed containers, with the batch number on every container and retention samples held against the declared retention period. Where a buyer requires filled and labelled vials at scale, that is a separate route and we will quote it as such.
Classification and duty
API supply into India falls under Chapter 29 with the same 7.5% BCD and 18% IGST structure as research-grade material. Where the material is a genuine medicament rather than a research chemical, the classification and licensing requirements change materially — our HS code and import duty page sets out the difference and why the Chapter 29 line is usually the right home for research material.
We will not quote API for a human therapeutic end-use without a written regulatory position from the buyer. Research and in-vitro application is the scope of our supply.
How a supply programme starts
- Specification agreement — sequence, counter-ion, purity floor, peptide content, packaging, documentation set and acceptance criteria, all in writing
- Qualification lot — a small batch delivered with the full document pack, verified independently on your side
- Validation — your QA function reviews the record set against your requirements
- Supply agreement — volumes, lead times, price validity, claim terms and governing law
- Scheduled supply — regular deliveries against the agreed specification, with a standing document template
Step two is where most programmes succeed or fail. We would rather qualify one lot properly than supply ten that cannot be verified.
Custom synthesis and batch scale
Sequences outside our catalogue can be supplied at API scale through our custom synthesis route, with feasibility confirmed before quotation. Long sequences, heavily modified constructs and very high-mass peptides carry different timelines and we will state them honestly rather than optimistically.
To start a conversation, send the sequence, the target specification, the annual volume and the destination. The trade desk will respond with a formal quotation and a documentation proposal.
B2B trade only — request a quote
All peptides are research-grade, for in-vitro use only, and supplied against a valid drug licence. Tell us your sequence, quantity and destination and the trade desk will respond within one business day.