USA Manufactured · FDA Registered · NDC per Peptide
The only peptide API supplier that is FDA registered, USA manufactured, and NDC registered per compound.
US
Made in the USA
≥99%
Avg. Purity (HPLC)
NDC
Registered per Peptide ISO 9001
ISO 9001
Quality Management Certified
KY BOP
Board of Pharmacy Licensed
Why We Exist
The peptide supply chain has a transparency problem.
Most peptide APIs sold to US compounding pharmacies originate as raw powder manufactured overseas — primarily in China — and are then imported, repackaged, and sold under a US company name. The “Made in USA” label often refers only to the final packaging step, not the manufacturing.
This matters because compounding pharmacies bear the full regulatory burden of the finished product. When the FDA or a state board asks where your API came from, “a US distributor” is not a sufficient answer. You need a documented, verifiable chain of custody — and that chain has to start at manufacturing.
Pure Peptide Solutions was founded to provide exactly that: peptides manufactured in a US-based cGMP facility, registered with the FDA, assigned an NDC per compound, and tested by an independent third-party laboratory before any material ships.
| Factor | Pure Peptide Solutions | Typical Supplier |
|---|---|---|
| Manufactured origin | USA (domestic cGMP facility) | China / India (often undisclosed) |
| NDC Numbers | Yes — per peptide | Rarely |
| FDA Registration | Yes — verifiable in FDA database | Varies; many are unregistered |
| Certificate of Analysis (COA) | Independent third-party lab | Often in-house or third-party unaccredited |
| Endotoxin testing (LAL) | Every lot | Selective or on request |
| SDS & Specification Sheet | Available with every order | Available on request (if at all) |
What Sets Us Apart
Four things no other peptide API supplier can claim together.
Manufactured in the USA
Our peptides are manufactured domestically in a US-based cGMP facility — not imported as raw powder from overseas and relabeled. In an industry where the vast majority of ‘USA made’ claims mask Chinese-origin raw material, we provide full documentation from manufacturing to shipment.
NDC Registered Per Peptide
Every peptide API we supply carries its own National Drug Code (NDC) — the FDA’s official identifier for drugs in the United States. An NDC means our products are listed in the FDA’s National Drug Code Directory, giving your pharmacy a fully traceable, auditable source that satisfies state board and DEA documentation requirements. Most API suppliers do not hold NDC registrations.
FDA Registered Manufacturer
Full Transparency — Every API
NDC Registration — Why It Matters
An NDC is not a marketing claim. It is an FDA-assigned identifier.
The National Drug Code (NDC) is a unique three-segment number that serves as the FDA’s official identifier for drugs in the United States. The FDA publishes all listed NDC numbers in the NDC Directory, which is updated daily and is publicly searchable.
For a bulk drug substance to carry an NDC, the manufacturer must be registered with the FDA as a drug establishment and must list the product in structured product labeling (SPL). This is not a self-certification — it requires FDA acceptance of the listing submission.
Pure Peptide Solutions holds an NDC for each peptide API in our catalog. This means every product you purchase from us has a verifiable, FDA-traceable identifier that you can reference in your pharmacy’s dispensing records, compliance documentation, and state board submissions.
- Satisfies state board of pharmacy documentation requirements
- Provides an FDA-verifiable, auditable source for your compliance records
- Enables accurate drug product listing in pharmacy dispensing systems
- Reduces risk during state board inspections and DEA audits
- Confirms the API is listed in the FDA's official National Drug Code Directory
What Every Order Includes
Full documentation. No exceptions. No requests needed.
Certificate of Analysis (COA)
Identity (LC-MS), purity (RP-HPLC), endotoxin (LAL), sterility (USP <71>) from an independent third-party lab.
Safety Data Sheet (SDS)
GHS-compliant SDS covering all 16 sections — hazard identification, handling, storage, disposal, and regulatory status.
Specification Sheet
NDC Number
GMP Compliance Letter
Cold-Chain Shipping
Who We Serve
Qualified buyers only. Always.
We do not sell to unverified parties, retail customers, or individuals. Every account is thoroughly reviewed and credentialed before access is granted.
503A Compounding Pharmacies
503B Outsourcing Facilities
Research Institutions
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