As blockbuster drugs come off patent, the Generics industry is poised to make a difference in people’s lives all over the world – providing access to medication that they previously couldn’t access or afford. With advances in analytical technology such as UPLC, and the USP's initiative to likewise modernize compendial methods, generic pharmaceutical organizations are in a stronger position than ever to upgrade laboratories and improve productivity, efficiency, and be more confident in product quality.
Manufacturers of generic drugs must be able to prove that the compounds they produce are comparable to the brand-name drug while maintaining and/or improving the cost effectiveness of the drug’s production.
Generic drug producers refer to the United States Pharmacopeia-National Formulary (USP-NF), as well as the British, European, and Japanese Pharmacopeias for information on how to analyze drug substance, drug product, and associated excipients using various analytical techniques such as high performance liquid chromatography (HPLC).
With the USP's initiative to modernize compendial methods to modern analytical technology, there are opportunities for generics QC labs to upgrade technologies and methods.
Complementing our analytical technologies for generic pharmaceutical QC labs are Waters' informatics products, smart tools that will help your laboratory operate more efficiently