GSI Pharmaceuticals Europe Limited

Since 2001, GSI Pharmaceuticals Europe Limited has been actively developing specialty products for API markets in Europe and other countries. We started our operations with the global marketing of a North American based integrated manufacturer of Lactulose and successfully partnered with European pharmaceutical companies to introduce our product to market.

Today, GSI Pharmaceuticals Europe has grown to offer a complete range of APIs as well as finished pharmaceutical specialties. Since the advent of EU directives 2004/27 and 2004/28, GSI Pharmaceuticals Europe is your ideal source of APIs from GMP-compliant sources. Leveraging on our US affiliate's over thirty years experience GMP compliance, drug master files, and plant audits/inspections with the FDA, we have the resources in place to reliably and efficiently supply your API needs.

The GSI Pharmaceuticals team includes a full-service in-house regulatory and compliance group. In addition to reviewing DMFs, GSI Pharmaceuticals's audit team frequently inspect facilities so as to both prepare them for GMP compliance as well as ensure ongoing compliance in line with the applicable regulatory changes and industry best practices. We also offer training for API manufacturing personnel with respect to DMF preparation and GMP compliance matters. Our experience and proven track record is measured in the success of our partner API manufacturers and our clients. In addition to the distribution of APIs, GSI Pharmaceuticals's network allows us to offer opportunities in outsourcing, technology transfers, and custom synthesis with a view to the long-term supply of strategic compounds.

GSI pharmaceutical's division serves the client who is looking to rationalize their production resources or want to augment their product lines by outsourcing production of certain dosage forms. By combining a source of GMP-compliant APIs, finished dosage production, and technology transfers, GSI Pharmaceuticals can provide you with a competitive solution to meet your strategic needs.

Our partner companies can also offer process optimization for novel molecules in order to advance their commercial scale development and we are also in a position to offer certain CRO services.

The success of GSI Pharmaceuticals team is built on our target solutions and strategy standard: From Molecule to Market.

 

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