GMP Excipients

GMP Excipients from Aceto

Aceto, through its recent acquisitions, has become a leading global GMP excipients manufacturer to the life sciences industry, offering our customers a broad portfolio of excipients. Our excipients are currently employed in vaccines, injectables, dermal, transdermal, topical and solid dosage finished drugs. 

 

The experience of Aceto as a global GMP excipient manufacturer has reaffirmed that each customer has unique product needs requiring tailored solutions. Our highly skilled and experienced R&D teams will work in unison with our customers to understand their product issues and to develop the necessary customized GMP solutions, such as GMP custom ingredient development, GMP manufacturing and GMP custom packaging. We also provide technical, quality and regulatory support throughout the entire sales cycle, from initial enquiry to full-scale GMP production.

 

Pharmaceutical excipients are substances other than the active pharmaceutical ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system. Excipients play a central role in the drug development process, in the formulation of stable dosage forms and in their administration.

Excipients have different roles in a formulation. Some of the major roles include:

  • - Aid in the processing of the drug delivery system during its manufacture.
  • - Protect, support or enhance stability, bioavailability or patient acceptability.
  • - Assist in product identification and enhance any attribute of the overall safety.
  • - Assist in the effectiveness and/or delivery of the drug in use.
  •  - Assist in maintaining the integrity of the drug product during storage.

 

As a long-standing global excipient manufacturer, Aceto has developed numerous customized GMP excipients over the years. Our excipients are manufactured in accordance to GMP and meet all current governing monographs where applicable, including USP, EP, BP, IP, JP and multi-compendial grade.

 

Aceto also specializes in further processing excipients to make them GMP compliant through a GMP manufacturing process. If you require an excipient to meet a current monograph or to be brought under GMP please contact our team

Below is a list of excipients readily available in various compendia with all associated supporting documentation.

 

Contact us if you need a custom formulation for any excipient

Excipients manufacturing

Quality Systems

Our EXCiPACT certification validates our compliance with global standards and processes. Our Quality Assurance team adheres proactively to the guidance from various regulatory bodies and stays up-to-date with all their latest recommendations. All necessary declarations and documentation support are provided to our customers enabling them to qualify for their audits successfully.

 

Excipients are manufactured in accordance to GMP and meet all current monographs where applicable, including USP, Ph. Eur, BP, JP and multicompendial grade.