Innovation Hub
Formulation Research Centre & Synthetic API R&D – Navi Mumbai
Formulation research forms a cornerstone of RPG’s long-term growth strategy. Our Formulation R&D teams are proficient in delivering innovative, patentable, branded as well as generic formulations. We possess deep capabilities to develop complex dosage forms including niche products using specialized technology platforms such as moisture-sensitive drug stabilization for both domestic and global regulated markets.
"Our development laboratory is equipped with advanced equipment, capable of handling small experimental batches to pilot scale trials for process optimization and tech transfer."
Our API R&D division specializes in identifying and developing non-infringing synthetic routes for active pharmaceutical ingredients. Working with catalytic pressure reactions, chiral chemistry, sophisticated reaction calorimeters, and scalable kilo labs, the team ensures robust tech transfer directly to our cGMP commercial manufacturing facilities.
FACILITIES & EXPERTISE
Specializing in solid oral dosages, modified-release pellets, and moisture-sensitive drug formulations for both domestic and regulated international markets.
Dedicated to non-infringing organic synthesis routes, scale-up from milligram to commercial multi-ton batches, and impurity risk mitigation.
Equipped with HPLC, headspace GC, and ICH stability test chambers for comprehensive impurity profiling and analytical method validations.
INTELLECTUAL PROPERTY
Granted live patents developed through formulation and API process research at RPG Life Sciences.
Controlled degradation and enhanced in-vitro dissolution is achieved by use of novel excipients (Croscarmellose sodium, Microcrystalline cellulose and PVP) and coating system comprising polyvinyl alcohol as film former, soya lecithin as plasticizer and solubilizing agent, and xanthan gum as stabilizer and suspension agent.
Drug delivery solid dosage formulation of sirolimus having improved in-vitro dissolution where Sirolimus is treated with a complexing agent and wetting agent in dissolved state.
Novel process is disclosed for manufacturing of key intermediate of Tolvaptan, i. e. "7-Chloro-5-oxo-1-(2-methyl-4-aminobenzoyl)-2,3,4,5-tetrahydro-1H-1-benzazepine".
An industrially scalable process for the preparation of benzazepine derivative (Tolvaptan) with more than 80% yield of final API.
An improved process for the preparation of Cinacalcet Hydrochloride and its intermediate 'Sodium {1-hydroxy-3-(3-trifluoromethyl phenyl) propyl} sulfonate' (Bisulphite adduct).