Master Formulae definition
Master Formulae means the definition of the manufacturing procedure and composition of the Active Drug Substance and a Product including, without limitation, the processing operations, the components and composition, equipment and devices employed and the necessary in-process controls, all as set forth in the relevant Regulatory Approval.
Examples of Master Formulae in a sentence
Should CoTherix or its Affiliates or Sublicensees desire to make any changes in the Master Formulae or Specifications of Products or Active Drug Substance, then CoTherix shall first disclose the same to the Joint Technical Committee for its approval.
CoTherix shall disclose the Master Formulae and Specifications for Products to be manufactured by or for it or its Affiliates or Sublicensees to the Joint Technical Committee for its approval.