Swissmedic GMP Certificate
Bachem AG, Hauptstrasse 144, 4416 Bubendorf — certified for Good Manufacturing Practice under Swiss regulations, aligned with PIC/S and recognised under the EU / USA / Canada–Switzerland Mutual Recognition Agreements.
Origin of materialSwiss-made API.
Swiss-made API.
American release testing.
The single largest variable in peptide research is the ingredient itself. We removed that variable at the top of the chain. The active peptide API behind our catalogue is Swiss-made by Bachem AG, Bubendorf — the same grade of pharmaceutical active ingredient supplied into regulated drug programs and compounding pharmacies worldwide. We then fill, seal and independently release-test in the United States, and we publish the certificate for the exact lot in your hand.
Tested and shipped from the USAShipped worldwide, including the UKNew Zealand sourced
The credentials behind the ingredient
These are the manufacturer's published regulatory credentials for the Bubendorf drug-substance site. They describe the origin of the active ingredient — they are not, and are not presented as, approvals of any Becker Global Labs product.
FDA-Inspected API Facility
The Bubendorf drug-substance site has been inspected by the U.S. FDA under the Active Pharmaceutical Ingredient program (CP 7356.002F) against ICH Q7 — a systems-based inspection covering Quality, Production, Materials, Facilities, Laboratory and Packaging, closed with no Form 483 observations issued.
Drug Master Files & CEPs
18 Drug Master Files and 9 Certificates of Suitability to the European Pharmacopoeia sit behind the manufacturer's peptide portfolio — the regulatory dossiers that innovator and generic drug programs are built on.
Integrated Quality Organisation
Over 20% of the manufacturer's workforce is dedicated to quality and regulatory functions: rigorous analytics, full impurity profiling, stability programs and a proven record with Swiss, EU, US and Japanese authorities.
Source documents are published by the manufacturer at bachem.com/quality-and-regulatory.
Bubendorf to bench — the full chain
- 01 — SynthesisBubendorf, Switzerland
Active peptide ingredient is manufactured under Swiss GMP by Bachem AG, the world's reference house for peptide APIs. Identity, sequence and impurity profile are established at the source under ICH Q7 controls.
- 02 — Import & Chain of CustodySealed, cold, documented
Material moves under temperature-controlled, tamper-evident custody with the manufacturer's documentation travelling with the container. Nothing is decanted, blended or re-labelled in transit.
- 03 — Fill & LyophilisationUnited States
Vials are filled and lyophilised in the USA in controlled conditions, sealed under amber crimp, and assigned a Becker Global Labs lot in the PRODUCT-STRENGTH-YYMMDD-RUN format plus a separate internal batch number.
- 04 — Independent Release TestingBioviridian, USA
Every lot is released only after independent third-party analysis — RP-HPLC purity, mass confirmation, appearance, endotoxin and heavy metals. The certificate is published on this site, lot-matched and scannable from the vial.
Same ingredient origin. Different, and strictly limited, purpose.
Sourcing pharmaceutical-grade API is a statement about material quality only. It is not a statement about use. Becker Global Labs products are supplied for Research Use Only. They are not drugs, not dietary supplements and not medical devices. They are not sterile injectables, are not intended for human or veterinary administration, and are not for diagnostic or therapeutic use of any kind. Nothing on this page constitutes a medical claim, and no product here is approved by the FDA, EMA or Swissmedic for any indication.
Purchasers confirm they are qualified researchers or institutions and that material will be handled by trained personnel in an appropriate laboratory setting, in accordance with all applicable law.