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GMP CUSTOM INGREDIENT DEVELOPMENT
A&C can meet the needs of new or custom excipients or raw materials through hands-on process development based on proven purification strategies such as distillation and crystallization. We provide GMP-compliant custom ingredient development and GMP-compliant manufacturing by creating robust, convenient, and cost-effective processes for pharmaceutical ingredient preparation.
Over the last 50 Years R&D team made an impact that is strong & we have long way to go.
Our R&D team has over fifty years of problem-solving experience and exceptional skills in developing scalable systems focused on simplicity, power, and timeliness. For many years, we have provided drug delivery solutions to pharmaceutical and biopharmaceutical companies worldwide.A&C uses one of the world’s leading project management tools to provide cost-effective and timely solutions to all our partners.
Our project management tools give our clients access to real-time information on their projects 24/7.If the customer requires additional materials or other equipment manufactured in a full GMP process, A&C will clearly provide this service and complete documentation will be provided.
All products are supplied with a full documentation archive to support your application and a Drug Master File (DMF) can be provided for selected products. For over fifty years, A&C has provided GMP manufactured products, ingredients, preservatives and APIs to meet customer needs. If your company requires standardized and tested formulations, purity, pH, GMP products, we are experts in providing customized solutions through innovative and well-designed methods..
A&C’s GMP custom ingredient and GMP manufacturing process is composed of 5 main phases:
1. Initiation phase
A&C can meet the demand for unique or customized excipients or raw materials by using a pragmatic approach to process development that is founded on tried-and-true purifying techniques like distillation and crystallization. We provide GMP manufacturing and GMP bespoke ingredient creation by creating reliable, useful, and affordable pharmaceutical ingredient production procedures.
2. Development phase
To fulfill your needs, a committed project team will start small-scale development. Raw materials from the development phase will be sent to you for your internal assessment. To get the intended outcome, this phase could involve several processes. Following your clearance, we’ll proceed to the upscaling stage.
3. Upscaling phase
Our Process Development Department receives the product in development phase and uses it for large-scale manufacturing trials. You will determine whether this trial product still satisfies your needs. You still have time to make minor changes in this phase depending on your assessment.
4. Validation phase
During this stage, our own protocols grounded on GMP manufacturing standards are used to validate the manufacturing process. You can utilize this product for your commercial production once our validation and clearance process is successfully completed.
5. Commercial phase
Our regular organization incorporates the newly developed excipients or raw materials, which will be given in accordance with the prearranged terms.