Active pharmaceutical ingredients
Mylan Labs' Contract Manufacturing Services (CMS) offer world class products and services related to the manufacturing of intermediates andactive pharmaceutical ingredients(APIs), from advanced clinical supplies to trade-demand quantities.
Mylan Labs works with pharmaceutical companies to provide services that enable its partners to bring their products to market at a lower manufacturing cost and with all required regulatory support. As an API supplier to generics pharmaceutical companies, Mylan Labs has proven expertise in the API business, and hence any product extensions and related products come at an attractive development cost.Our services include:
- Conduct scale-up studies for a given process,
- Conduct boundary evaluations,
- Conduct Rapid technology transfers,
- Undertake a reduction in cost of goods on existing processes,
- Manufacture validation batches,
- Undertake commercial manufacturing of the API / NCE / Intermediate
Mylan Labs' CMS business focuses on Lifecycle Management (Contract Manufacturing of APIs nearing the patent protection period), supply of API for novel Fixed Dose Combinations (FDCs) and Chemical Class Extensions (NCEs with matching chemistries of Mylan's existing portfolio).