GMP certificate
Bachem AG, Bubendorf: certified for Good Manufacturing Practice under Swiss regulations, aligned with PIC/S and recognised under EU, US and Canada mutual recognition agreements.
Origin of material
Swiss-made API. American release testing.
The ingredient is the largest variable in peptide research, so we addressed it at the top of the chain: pharmaceutical-grade API from Bachem, Switzerland, filled and independently tested in the United States.
Manufacturer credentials
The credentials behind the ingredient.
Published regulatory credentials of the Bubendorf drug-substance site. They describe the origin of the active ingredient, not approvals of any Becker Global Labs product.
Inspected API facility
Inspected under the FDA Active Pharmaceutical Ingredient program against ICH Q7, covering quality, production, materials, facilities, laboratory and packaging systems.
DMFs and CEPs
18 Drug Master Files and 9 Certificates of Suitability to the European Pharmacopoeia support the manufacturer’s peptide portfolio.
Integrated analytics
More than 20% of the manufacturer’s workforce works in quality and regulatory functions: full impurity profiling, stability programmes and analytics.
From Bubendorf to bench
The full chain, step by step.
- 01Bubendorf, Switzerland
Synthesis
Active peptide ingredient is manufactured under Swiss GMP by Bachem AG. Identity, sequence and impurity profile are established at the source under ICH Q7 controls.
- 02Sealed, cold, documented
Import & chain of custody
Material moves under temperature-controlled, tamper-evident custody with the manufacturer’s documentation. Nothing is decanted, blended or relabelled in transit.
- 03United States
Fill & lyophilisation
Vials are filled and lyophilised in controlled conditions, sealed under amber crimp and assigned a Becker lot number plus an internal batch number.
- 04Bioviridian, USA
Independent release testing
Each lot is released only after third-party analysis: RP-HPLC purity, mass confirmation, appearance, endotoxin and heavy metals. The certificate is published and scannable from the vial.
Sourcing pharmaceutical-grade API is a statement about material quality only. Becker Global Labs products are supplied for laboratory research use and are not approved by the FDA, EMA or Swissmedic for any indication.
