en Sourcing, analyzing, repacking and delivery of high-quality pharmaceutical ingredients in your desired volume are our strengths. We only work with qualified manufacturers who meet EUGMP (Written Confirmation) requirements and preferably have an ASMF-CEP for their APIs; Ofipharma fully complies with the Falsified Medications Directive, which requires full traceability for all APIs.
Sourcing
Ofipharma has strong relationships with manufacturers of APIs around the globe and cooperates with the Ofichem sourcing office in Hangzhou (China). We can source globally and act locally
Approval manufacturing site
Audits of API manufacturers guarantee control of our product portfolio, securing that the product quality is in line with pharmacopoeia and ensuring that our APIs are produced in factories that are EUGMP compliant. Note: OFIDIT performs onsite audits upon request.
Purchasing and supply chain management
To ensure a timely GDP delivery we only work with approved logistic partners who have a proven track record in import and export.
Sampling
Sampling is performed in our GMP cleanrooms. In addition, we sample, analyze and keep stock of bulk APIs prior for release by CMOs.
Analyzing
The raw materials we supply can be tested (reanalyzed) in our selected GLP labs, against the latest Pharmacopoeia monographs and will be provided with appropriate documentation.
Repacking
We can repack bulk into the packing size you need in our GMP facility. The raw materials in our range are not only available in standard presentations/bulk, but can also be repacked in any size you require.
Release
The results of reanalysis and extensive range of documents are reviewed by our QA department before the products are released.