Dr. Reddy's Custom Pharmaceutical Services (CPS) explains the integration of highly potent drug substance and drug product manufacturing.
High potency active pharmaceutical ingredient (HPAPI) production is the fastest growing segment of the pharmaceutical market. Specialist facilities and expertise are needed for the safe manufacture of high potency drugs. Dr Reddy’s Custom Pharmaceutical Services (CPS) offers integrated drug substance (DS) and drug product (DP) development and manufacture of highly potent compounds. An integrated manufacturing chain means that all the processes are carried out within one organisation. This requires facilities where the DS and DP processes can be interlinked allowing for symbiosis of expertise. Streamlining the manufacturing chain by integrating processes has several advantages for the customer, such as risk mitigation, reduced time-lines and cost effectiveness.
CPS has modern facilities designed to handle highly potent DS and/or DP development and manufactures at its sites in Vizag and Hyderabad, India. CPS can handle steroids and prostaglandins at various scales and manufactures at its facilities in Mexico and the UK. The manufacturing facilities are (FDA and EMEA) approved for supply to regulated markets for worldwide distribution. The site has standard operating procedures on how to handle material from an occupational exposure-limit perspective, with the goal of protecting the people, environment and the product from cross-contamination.