Aurigene wins RE Pharma award; contributes to two US FDA Novel Drug approvals

New Delhi: Aurigene Pharmaceutical Services Limited, a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), has been honored with the RE Pharma Award for ‘Excellence in Pharma Contract Manufacturing Services’ by ET Pharma, further reinforcing its growing impact in enabling innovative therapies worldwide.

In a significant milestone year, Aurigene also served as the primary API manufacturer for two of the 46 Novel Drug Approvals granted by the (USFDA) in 2025. For one of these approved therapies, Aurigene additionally acted as the sole Drug Product (DP) manufacturer, demonstrating its integrated capabilities across both API and finished dosage development and manufacturing.

Strengthening its formulation and manufacturing expertise, Aurigene has successfully executed exhibit batches for an oral solution and an injectable product. One among these is an antibiotic for the treatment of uncomplicated gonorrhea, addressing a significant global public health burden. The other product remains undisclosed.

These programs were executed from Aurigene’s USFDA-approved manufacturing facilities, ensuring the highest standards of quality, compliance, and reliability.

Commenting on the achievement, Akhil Ravi, CEO at Aurigene Pharmaceutical Services Limited said: “These milestones reflect years of deep collaboration with innovator partners and seamless integration across research, manufacturing, and supply chain. The USFDA Novel Drug Approvals, underscores our ability to deliver complex, high-quality APIs and formulations that accelerate the journey of innovative therapies to patients globally.”