• Regulatory guidelines Unclear guidelines can make it difficult to develop a product and get it approved.
• Manufacturing The manufacturing process can be complex and involve the use of uncommon equipment.
• Quality The quality of raw materials and excipients can affect the product's stability and lead to degradation.
• Sterilization Insufficient sterilization can be a problem.
• Scale-up Scale-up processes can be tedious due to the complexity of the manufacturing process.
• Approval The approval process can be challenging due to the need for non-conventional testing and the lack of clarity in regulatory requirements.
• Delivery device The right delivery device for the drug substance needs to be carefully considered.
• Safety Small molecules are more prone to safety challenges than biologics.

Small molecule injectable drugs are often necessary for the treatment of hospital patients. Production of sterile injectable projects is much more complex and challenging than oral dose manufacturing. A commitment to quality, robust processes and knowledge of the end user are essential for CDMOs providing these services.

• Clear understanding of regulatory requirements.
• Better understanding on formulation development
• Appropriate response to regulatory queries on time; or no query objective