search
Piramal Pharma Limited, Ennore Express Highway, Ennore, Chennai – 600057, India
Piramal’s Ennore facility provides process development and early-phase clinical supplies for NCEs, as well as custom manufacturing services for RSMs, KSMs, and intermediates. The plant has a total capacity of 200+ MT per year. The facility has received regulatory accreditations from WHO GMP and India FDA
The facility specializes in route scouting and chemical development. It also offers the development of Phase I and II clinical batches of APIs in compliance with GMP. Our expertise extends to manufacturing intermediates at various scales, supported by strong experience in seamless scale-up processes.
Total capacity of our multi-purpose plant is 200+ metric tons per year. Our pilot plant can handle batches from 2 to 20 kilograms. Our cGMP Kilo lab is capable of handling 0.5 kg to 15 kg. We specialize in the commercial-scale execution of complex reactions like Cyanation, Hydrogenation, and Qzonolysis ensuring efficient production.
The facility offers expertise in asymmetric synthesis through stereo-selective methods utilizing chiral ligands, chiral pool chemistry, chiral reagents, and chemical resolution. It also specializes in heterocyclic synthesis, carbohydrate chemistry, organofluorine, transition metal-catalyzed reactions, and impurity profiling.
The facility offers comprehensive services for route scouting, chemical development, and seamless on-site manufacturing, ensuring efficient production processes. It specializes in supplying API Phase I and II clinical batches adhering to GMP standards.
The facility provides services for analytical method development & validation. It also offers impurity isolation and characterization, reference standard qualification, and conducting stability studies following ICH guidelines.