Formulation Development Center (FDC): Oral Small-Molecule Drug Product Development & Manufacturing

Discover how Syngene accelerates oral and complex formulations through integrated DS‑DP‑Analytical workflows and advanced enabling technologies like SDD, HME, and nanosuspensions. Read how our GMP facilities, digital QA systems, and proven scale‑up expertise drive faster FIH and late‑phase readiness.
Sterile Fill-Finish facility: Your integrated partner for customized clinical supplies
Syngene’s Sterile Fill-Finish facility is custom-built to meet market demand for clinical supply of sterile drug products having short development timelines.
Partnering for Analytical Excellence

Explore how Syngene delivers precise, regulatory‑ready analytics backed by 300+ scientists, digital quality systems, and one of Asia’s largest ICH stability infrastructures. See how lifecycle‑aligned methods and deep characterization capabilities enhance speed, compliance, and data integrity.
Nitrosamine Impurity Testing Services
Syngene’s Center of Excellence for Nitrosamine impurity testing supports formulation requirements for small molecule APIs, key sourcing materials, and intermediates.
ICH Stability services
One of the largest Stability facilities in Asia, Syngene supports both small molecules and biologics from early development to CMC
Clinical Development services

Syngene supports early-phase to late-phase clinical trials required for drug development programs across a wide range of therapeutic areas.
Comprehensive solutions for Clinical Development of generic drugs
Synene has developed more than 100 assays for conducting BA/BE studies across small molecules and biologics.
Commercial Manufacturing services

Syngene supports manufacturing of regulatory starting materials, APIs, HPAPI, NCEs and novel advanced intermediates
Complimentary techniques for determining relative response factor of non- isolated impurities

Understanding the concept behind determining UV RRF of non-isolated impurities using High Performance Liquid Chromatography and Nuclear Magnetic Resonance
The many benefits of outsourcing Stability: A Baxter-Syngene Case study
Learn why Baxter chose to partner with Syngene for Stability studies, the business flow, governance mechanism and metrics that were implemented, which enabled a mutually successful collaboration.