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GMP CUSTOM MANUFACTURING
As a highly skilled and knowledgeable manufacturer of excipients, A&C can copy your existing processes and formulations for all raw materials, provide GMP bespoke production, or create custom formulations. This ensures quality as well as technical and product assurance.
Following the completion and validation of the A&C designed method, the product undergoes an extended stability testing phase. After that, the product is produced, packed, and distributed in complete GMP compliance.
About GPM Custom Manufacturing
For our international clientele, A&C provides custom-made excipients, buffers, and process solutions that enable us to quickly address their needs in preclinical, phase I, II, or III clinical trial, or commercial finished drug manufacturing. With more than 50 years of experience producing excipients, A&C has the technical, regulatory, and quality know-how to address a broad range of GMP concerns for our clients. This includes offering a number of specialized solutions, such as GMP bespoke production of excipients and raw materials.
A&C has been effectively producing a wide range of raw materials on demand, including buffers, process solutions, binders, solvents, preservatives, lubricants, antioxidants, and a few APIs. All of these products are produced in accordance with GMP and the necessary regulating regulations.
Every product is also included to A&C’s supply chain and quality management system. We value quality, transparency, and change control, thus all of our procedures are made to ensure that clients are informed of any significant changes in a timely manner. A&C works with several raw material suppliers to have secondary sources approved whenever possible in order to further reduce our customers’ risk.